Data / Medical devices / United States / Exel Inc. Dba DHL Supply Chain (usa)

Exel Inc. Dba DHL Supply Chain (usa): FDA-registered device maker in Mooresville, IN, United States, 823 510(k) clearances and 1 PMA approval

Name: Exel Inc. Dba DHL Supply Chain (usa) FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Exel Inc. Dba DHL Supply Chain (usa) is registered with the FDA (registration 3008868758) in Mooresville, IN, United States. It lists 131 device types. The FDA files 823 510(k) clearances and 1 PMA approval under its listings, the newest dated April 8, 2021. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this one Watch Exel Inc. Dba DHL Supply Chain (usa)

FDA registration number: 3008868758
Address: 9440 South State Road 39 Suite 200, Mooresville, IN, United States, 46158
Owner or operator: Exel Inc. dba DHL Supply Chain (USA) (10026656)
Roles: Repackager or relabeler
First device listed: November 15, 2021
Registered through: 2026
Brand names listed: (TRANSFERRED) STEAM STERILIZATION UPDATE (REMOVED MR COMPATIBILITY] FOR MULTIPLE TRAUMA INTERNAL FIXATION SYSTEMS (BUNDL, 1.3 & 1.5MM CONTOURABLE TITANIUM (TI.) MESH PLATES, 2.4 MM VA-LCP VOLAR RIM DISTAL RADIUS SYSTEM, 2.4MM CORTEX SCREW, SELF-TAPPING, 2.4MM VA-LCP DORSAL DISTAL RADIUS PLATES, 2.4MM VA-LCP INTERCARPAL FUSION SYSTEM, 2.7/3.5MM VA-LCP ANTERIRO CLAVICLE PLATE SYSTEM, 2.7MM LCP ULNA OSTEOTOMY SYSTEM and more

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Arthroscopic	NBH	1	Repackager or relabeler	accessdata.fda.gov
Accessory, Surgical Apparel	LYU	1	Repackager or relabeler	accessdata.fda.gov
Anchor, Suture, Bone Fixation, Metallic	NOV	2	Repackager or relabeler	accessdata.fda.gov
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	KTT	2	Repackager or relabeler	accessdata.fda.gov
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite	LXT	2	Repackager or relabeler	accessdata.fda.gov
Appliance, Fixation, Nail/Blade/Plate Combination, Single Component	KTW	2	Repackager or relabeler	accessdata.fda.gov
Appliance, Fixation, Spinal Interlaminal	KWP	2	Repackager or relabeler	accessdata.fda.gov
Appliance, Fixation, Spinal Intervertebral Body	KWQ	2	Repackager or relabeler	accessdata.fda.gov
Arthroscope	HRX	2	Repackager or relabeler	accessdata.fda.gov
Blade, Saw, General & Plastic Surgery, Surgical	GFA	1	Repackager or relabeler	accessdata.fda.gov
Bone Cement	LOD	2	Repackager or relabeler	accessdata.fda.gov
Bone Cement, Posterior Screw Augmentation	PML	2	Repackager or relabeler	accessdata.fda.gov
Brace, Drill	HXY	1	Repackager or relabeler	accessdata.fda.gov
Bur, Surgical, General & Plastic Surgery	GFF	1	Repackager or relabeler	accessdata.fda.gov
Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation	OIS	2	Repackager or relabeler	accessdata.fda.gov
Cement Obturator	LZN	2	Repackager or relabeler	accessdata.fda.gov
Cement, Bone, Vertebroplasty	NDN	2	Repackager or relabeler	accessdata.fda.gov
Cerclage, Fixation	JDQ	2	Repackager or relabeler	accessdata.fda.gov
Component, Traction, Invasive	JEC	2	Repackager or relabeler	accessdata.fda.gov
Condylar Plate Fixation Implant	JDP	2	Repackager or relabeler	accessdata.fda.gov
Cover, Burr Hole	GXR	2	Repackager or relabeler	accessdata.fda.gov
Cover, Shoe, Operating-Room	FXP	1	Repackager or relabeler	accessdata.fda.gov
Cranial Distraction System	PBJ	2	Repackager or relabeler	accessdata.fda.gov
Device, Fixation, Proximal Femoral, Implant	JDO	2	Repackager or relabeler	accessdata.fda.gov
Dress, Surgical	FYE	1	Repackager or relabeler	accessdata.fda.gov
Drill, Bone, Powered	DZI	2	Repackager or relabeler	accessdata.fda.gov
Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece	ERL	2	Repackager or relabeler	accessdata.fda.gov
Drills, Burrs, Trephines & Accessories (Manual)	HBG	2	Repackager or relabeler	accessdata.fda.gov
Drills, Burrs, Trephines & Accessories (Simple, Powered)	HBE	2	Repackager or relabeler	accessdata.fda.gov
Driver, Wire, And Bone Drill, Manual	DZJ	2	Repackager or relabeler	accessdata.fda.gov
Electrosurgical, Cutting & Coagulation & Accessories	GEI	2	Repackager or relabeler	accessdata.fda.gov
External Mandibular Fixator And/Or Distractor	MQN	2	Repackager or relabeler	accessdata.fda.gov
Fastener, Fixation, Biodegradable, Soft Tissue	MAI	2	Repackager or relabeler	accessdata.fda.gov
Fastener, Fixation, Nondegradable, Soft Tissue	MBI	2	Repackager or relabeler	accessdata.fda.gov
Fastener, Plate, Cranioplasty	HBW	2	Repackager or relabeler	accessdata.fda.gov
Filler, Bone Void, Calcium Compound	MQV	2	Repackager or relabeler	accessdata.fda.gov
Growing Rod System	PGM	2	Repackager or relabeler	accessdata.fda.gov
Implant, Fixation Device, Spinal	JDN	2	Repackager or relabeler	accessdata.fda.gov
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	HWE	1	Repackager or relabeler	accessdata.fda.gov
Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment	HSZ	1	Repackager or relabeler	accessdata.fda.gov
Instrument, Surgical, Sonic And Accessory/Attachment	JDX	2	Repackager or relabeler	accessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, Cervical	ODP	2	Repackager or relabeler	accessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, Lumbar	MAX	2	Repackager or relabeler	accessdata.fda.gov
Intervertebral Fusion Device With Integrated Fixation, Cervical	OVE	2	Repackager or relabeler	accessdata.fda.gov
Intervertebral Fusion Device With Integrated Fixation, Lumbar	OVD	2	Repackager or relabeler	accessdata.fda.gov
Knee Arthroplasty Implantation System	OOG	2	Repackager or relabeler	accessdata.fda.gov
Lamp, Operating-Room	FQP	2	Repackager or relabeler	accessdata.fda.gov
Laparoscope, General & Plastic Surgery	GCJ	2	Repackager or relabeler	accessdata.fda.gov
Light Source, Fiberoptic, Routine	FCW	2	Repackager or relabeler	accessdata.fda.gov
Light, Surgical, Instrument	FSQ	2	Repackager or relabeler	accessdata.fda.gov
Mesh, Surgical	FTM	2	Repackager or relabeler	accessdata.fda.gov
Mesh, Surgical, Acetabular, Hip, Prosthesis	JDJ	2	Repackager or relabeler	accessdata.fda.gov
Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon	OWY	2	Repackager or relabeler	accessdata.fda.gov
Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery	OXH	2	Repackager or relabeler	accessdata.fda.gov
Mesh, Surgical, Collagen, Staple Line Reinforcement	OXE	2	Repackager or relabeler	accessdata.fda.gov
Mesh, Surgical, Collagen, Thoracic, Chest Wall Reconstruction	OXB	2	Repackager or relabeler	accessdata.fda.gov
Mesh, Surgical, Metal	EZX	2	Repackager or relabeler	accessdata.fda.gov
Mesh, Surgical, Non-Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed	PAJ	2	Repackager or relabeler	accessdata.fda.gov
Methyl Methacrylate For Cranioplasty	GXP	2	Repackager or relabeler	accessdata.fda.gov
Monitor, Pressure, Intracompartmental	LXC	U	Repackager or relabeler	accessdata.fda.gov
Motor, Drill, Pneumatic	HBB	2	Repackager or relabeler	accessdata.fda.gov
Nail, Fixation, Bone	JDS	2	Repackager or relabeler	accessdata.fda.gov
Nasopharyngoscope (Flexible Or Rigid)	EOB	2	Repackager or relabeler	accessdata.fda.gov
Neurological Stereotaxic Instrument	HAW	2	Repackager or relabeler	accessdata.fda.gov
Neurosurgical Nerve Locator	PDQ	2	Repackager or relabeler	accessdata.fda.gov
Orthopedic Stereotaxic Instrument	OLO	2	Repackager or relabeler	accessdata.fda.gov
Orthosis, Spinal Pedicle Fixation	MNI	2	Repackager or relabeler	accessdata.fda.gov
Orthosis, Spine, Plate, Laminoplasty, Metal	NQW	2	Repackager or relabeler	accessdata.fda.gov
Orthosis, Spondylolisthesis Spinal Fixation	MNH	2	Repackager or relabeler	accessdata.fda.gov
Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis	OSH	2	Repackager or relabeler	accessdata.fda.gov
Pin, Fixation, Smooth	HTY	2	Repackager or relabeler	accessdata.fda.gov
Pin, Fixation, Threaded	JDW	2	Repackager or relabeler	accessdata.fda.gov
Plate, Bone	JEY	2	Repackager or relabeler	accessdata.fda.gov
Plate, Cranioplasty, Preformed, Alterable	GWO	2	Repackager or relabeler	accessdata.fda.gov
Plate, Cranioplasty, Preformed, Non-Alterable	GXN	2	Repackager or relabeler	accessdata.fda.gov
Plate, Fixation, Bone	HRS	2	Repackager or relabeler	accessdata.fda.gov
Posterior Cervical Screw System	NKG	2	Repackager or relabeler	accessdata.fda.gov
Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer	HSN	2	Repackager or relabeler	accessdata.fda.gov
Prosthesis, Condyle, Mandibular, Temporary	NEI	2	Repackager or relabeler	accessdata.fda.gov
Prosthesis, Elbow, Hemi-, Radial, Polymer	KWI	2	Repackager or relabeler	accessdata.fda.gov
Prosthesis, Elbow, Semi-Constrained, Cemented	JDB	2	Repackager or relabeler	accessdata.fda.gov
Prosthesis, Finger, Constrained, Polymer	KYJ	2	Repackager or relabeler	accessdata.fda.gov
Prosthesis, Hip, Cement Restrictor	JDK	2	Repackager or relabeler	accessdata.fda.gov
Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer	KWZ	2	Repackager or relabeler	accessdata.fda.gov
Prosthesis, Hip, Hemi-, Femoral, Metal	KWL	2	Repackager or relabeler	accessdata.fda.gov
Prosthesis, Hip, Hemi-, Femoral, Metal Ball	LZY	2	Repackager or relabeler	accessdata.fda.gov
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	KWY	2	Repackager or relabeler	accessdata.fda.gov
Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)	KWA	3	Repackager or relabeler	accessdata.fda.gov
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	LZO	2	Repackager or relabeler	accessdata.fda.gov
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	JDI	2	Repackager or relabeler	accessdata.fda.gov
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	LPH	2	Repackager or relabeler	accessdata.fda.gov
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented	LWJ	2	Repackager or relabeler	accessdata.fda.gov
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	MEH	2	Repackager or relabeler	accessdata.fda.gov
Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	NPJ	2	Repackager or relabeler	accessdata.fda.gov
Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer	KRO	2	Repackager or relabeler	accessdata.fda.gov
Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer	HSX	2	Repackager or relabeler	accessdata.fda.gov
Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Composite	KYK	2	Repackager or relabeler	accessdata.fda.gov
Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer	HRY	2	Repackager or relabeler	accessdata.fda.gov
Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer	KRR	2	Repackager or relabeler	accessdata.fda.gov
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	MBH	2	Repackager or relabeler	accessdata.fda.gov
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive	OIY	2	Repackager or relabeler	accessdata.fda.gov
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	JWH	2	Repackager or relabeler	accessdata.fda.gov
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing	NJL	3	Repackager or relabeler	accessdata.fda.gov
Prosthesis, Rib Replacement	MDI	2	Repackager or relabeler	accessdata.fda.gov
Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	HSD	2	Repackager or relabeler	accessdata.fda.gov
Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	KWT	2	Repackager or relabeler	accessdata.fda.gov
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	KWS	2	Repackager or relabeler	accessdata.fda.gov
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented	MBF	2	Repackager or relabeler	accessdata.fda.gov
Rasp	HTR	1	Repackager or relabeler	accessdata.fda.gov
Reamer	HTO	1	Repackager or relabeler	accessdata.fda.gov
Retention Device, Suture	KGS	1	Repackager or relabeler	accessdata.fda.gov
Retractor, Self-Retaining, For Neurosurgery	GZT	2	Repackager or relabeler	accessdata.fda.gov
Rod, Fixation, Intramedullary And Accessories	HSB	2	Repackager or relabeler	accessdata.fda.gov
Sacroiliac Joint Fixation	OUR	2	Repackager or relabeler	accessdata.fda.gov
Screw, Fixation, Bone	HWC	2	Repackager or relabeler	accessdata.fda.gov
Screw, Fixation, Intraosseous	DZL	2	Repackager or relabeler	accessdata.fda.gov
Shoulder Prosthesis, Reverse Configuration	PHX	2	Repackager or relabeler	accessdata.fda.gov
Software For Diagnosis/Treatment	OSN	2	Repackager or relabeler	accessdata.fda.gov
Spinal Vertebral Body Replacement Device	MQP	2	Repackager or relabeler	accessdata.fda.gov
Staple, Fixation, Bone	JDR	2	Repackager or relabeler	accessdata.fda.gov
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	KCT	2	Repackager or relabeler	accessdata.fda.gov
Stimulator, Nerve	ETN	2	Repackager or relabeler	accessdata.fda.gov
Suture, Absorbable, Synthetic, Polyglycolic Acid	GAM	2	Repackager or relabeler	accessdata.fda.gov
Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile	GAQ	2	Repackager or relabeler	accessdata.fda.gov
Suture, Nonabsorbable, Synthetic, Polyester	GAS	2	Repackager or relabeler	accessdata.fda.gov
Suture, Nonabsorbable, Synthetic, Polyethylene	GAT	2	Repackager or relabeler	accessdata.fda.gov
Suture, Surgical, Absorbable, Polydioxanone	NEW	2	Repackager or relabeler	accessdata.fda.gov
Syringe, Piston	FMF	2	Repackager or relabeler	accessdata.fda.gov
System, Facet Screw Spinal Device	MRW	U	Repackager or relabeler	accessdata.fda.gov
Thoracolumbosacral Pedicle Screw System	NKB	2	Repackager or relabeler	accessdata.fda.gov
Washer, Bolt Nut	HTN	2	Repackager or relabeler	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance. Newest 100 of 823.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
April 8, 2021	K210408	DePuy Synthes Variable Angle Locking Patella Plating System	HRS	Substantially Equivalent	Synthes (USA) Products, LLC	accessdata.fda.gov
March 18, 2021	K203186	DYNATAPE Suture	GAT	Substantially Equivalent	Medos International SARL	accessdata.fda.gov
February 1, 2021	K203794	HEALIX Ti Dual Threaded Suture Anchor with DYNATAPE Suture	MBI	Substantially Equivalent	Medos International SARL	accessdata.fda.gov
January 14, 2021	K202769	VELYS Robotic-Assisted Solution	OLO	Substantially Equivalent	Depuy Ireland UC	accessdata.fda.gov
December 16, 2020	K203414	DePuy Synthes 2.7mm VA LCP Clavicle Plate System, DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System	HRS	Substantially Equivalent	DePuy Synthes	accessdata.fda.gov
November 25, 2020	K202098	GLOBAL UNITE Platform Shoulder System	PHX	Substantially Equivalent	Depuy Ireland UC	accessdata.fda.gov
October 21, 2020	K202472	ACTIS Duofix Hip Prosthesis	LPH	Substantially Equivalent	DePuy Orthopaedics, Inc.	accessdata.fda.gov
September 23, 2020	K201346	DePuy Synthes Retrograde Femoral Nail Advanced System, DePuy Synthes Locking Screws for Medullary Nails, 5.0 mm	HSB	Substantially Equivalent	Synthes (USA) Products, LLC	accessdata.fda.gov
September 16, 2020	K201661	Symphony Navigation Ready Instruments and Universal Navigation Adaptor Set	OLO	Substantially Equivalent	Medos International SARL	accessdata.fda.gov
September 11, 2020	K200854	DePuy PINNACLE Dual Mobility Liner	LPH	Substantially Equivalent	Depuy Ireland UC	accessdata.fda.gov
September 10, 2020	K201944	DePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE Screws (26-40mm)	JEY	Substantially Equivalent	Synthes (USA) Products, LLC	accessdata.fda.gov
September 10, 2020	K201145	X-Pac Expandable Lumbar Cage System	MAX	Substantially Equivalent	Expanding Innovations, Inc.	accessdata.fda.gov
September 9, 2020	K201578	DePuy Synthes Variable Angle Locking Patella Plating System	HRS	Substantially Equivalent	Synthes (USA) Products, LLC	accessdata.fda.gov
September 3, 2020	K201336	DePuy Synthes Tibial Nail Advanced, Depuy Synthes Locking Screws Medullary Nails, 4.0 and 5.0mm	JDS	Substantially Equivalent	Synthes (USA) Products, LLC	accessdata.fda.gov
August 7, 2020	K201883	6.5 mm Healix Advance SP Peek Anchor, 6.5 mm Healix Advance SP Biocomposite Anchor	MBI	Substantially Equivalent	Medos International SARL	accessdata.fda.gov
July 31, 2020	K200791	Navigation Enabled Intruments	OLO	Substantially Equivalent	Medos International SARL	accessdata.fda.gov
July 24, 2020	K201321	DePuy Synthes 2.7mm VA LCP Clavicle Plate System	HRS	Substantially Equivalent	DePuy Synthes	accessdata.fda.gov
June 18, 2020	K201347	DePuy ATTUNE Total Knee System	OIY	Substantially Equivalent	DePuy Orthopaedics, Inc.	accessdata.fda.gov
June 16, 2020	K193540	TRUMATCH Personalized Solutions	JWH	Substantially Equivalent	DePuy Orthopaedics, Inc.	accessdata.fda.gov
April 24, 2020	K200245	EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine System	NKB	Substantially Equivalent	Medos International Sàrl	accessdata.fda.gov
April 2, 2020	K192646	SYMPHONY OCT System	NKG	Substantially Equivalent	Medos International SARL	accessdata.fda.gov
February 26, 2020	K191463	DePuy Synthes Hammertoe Continuous Compression Implant	JDR	Substantially Equivalent	Synthes (USA) Products, LLC	accessdata.fda.gov
February 24, 2020	K192855	DELTA XTEND(TM) Reverse Shoulder System	PHX	Substantially Equivalent	Depuy(Ireland)	accessdata.fda.gov
February 4, 2020	K193398	Summit DuoFix HA Coating	MEH	Substantially Equivalent	DePuy Orthopaedics, Inc.	accessdata.fda.gov
January 30, 2020	K193057	ATTUNE All-Polyethylene Tibia	JWH	Substantially Equivalent	Depuy Ireland UC	accessdata.fda.gov
January 24, 2020	K192014	SYPMHONY OCT System	NKG	Substantially Equivalent	Medos International SARL	accessdata.fda.gov
November 26, 2019	K192946	DePuy Corail AMT Hip Prosthesis	LZO	Substantially Equivalent	DePuy Orthopaedics, Inc.	accessdata.fda.gov
November 26, 2019	K192919	Pinnacle Duofix HA Acetabular Cup Prosthesis	LPH	Substantially Equivalent	DePuy Orthopaedics, Inc.	accessdata.fda.gov
November 7, 2019	K192327	DePuy Synthes 2.4mm LCP Straight Wrist Plate, Sterile	HRS	Substantially Equivalent	Synthes (USA) Products, LLC	accessdata.fda.gov
November 1, 2019	K190344	DePuy Corail AMT Hip Prosthesis	LZO	Substantially Equivalent	Depuy(Ireland)	accessdata.fda.gov
October 18, 2019	K191943	SYMPHONY Navigation Ready Instruments, Universal Navigation Adaptor Set	OLO	Substantially Equivalent	Medos International SARL	accessdata.fda.gov
October 8, 2019	K191779	Attune Revision LPS Inserts	KRO	Substantially Equivalent	Depuy(Ireland)	accessdata.fda.gov
August 22, 2019	K191242	HEALIX ADVANCE SP BIOCOMPOSITE Anchor	MAI	Substantially Equivalent	Medos International SARL	accessdata.fda.gov
July 25, 2019	K190774	RIGIDLOOP Titanium Button , RIGIDLOOP Cortical Fixation System XL Implant	MBI	Substantially Equivalent	Medos International SARL	accessdata.fda.gov
July 18, 2019	K190895	MOUNTAINEER OCT Spinal System, SUMMIT SI OCT Spinal Fixation System, SYMPHONY OCT System, SUMMIT Fixation System	NKG	Substantially Equivalent	Medos International SARL	accessdata.fda.gov
May 23, 2019	K183054	SYNMESH System	MQP	Substantially Equivalent	Depuy Synthes Spine	accessdata.fda.gov
May 17, 2019	K183618	Revolution Radial Head	KWI	Substantially Equivalent	Ignite Orthopedics, Inc.	accessdata.fda.gov
May 17, 2019	K183077	Delta Xtend Reverse Shoulder System	PHX	Substantially Equivalent	Depuy(Ireland)	accessdata.fda.gov
May 9, 2019	K181933	DePuy Synthes Sterilization Container System	KCT	Substantially Equivalent	Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.	accessdata.fda.gov
May 3, 2019	K190409	MatrixRIB Fixation System	HRS	Substantially Equivalent	DePuy Synthes	accessdata.fda.gov
February 26, 2019	K182941	HEALIX ADVANCE SP PEEK Anchor	MBI	Substantially Equivalent	Medos International SARL	accessdata.fda.gov
February 21, 2019	K183279	HEALIX Ti ANCHOR with DYNACORD	MBI	Substantially Equivalent	Medos International SARL	accessdata.fda.gov
February 14, 2019	K183506	HEALIX ADVANCE Anchor with DYNACORD Suture	MAI	Substantially Equivalent	Medos International SARL	accessdata.fda.gov
December 26, 2018	K182783	DePuy Synthes Trauma Orthopedic Nail Implants	HRS	Substantially Equivalent	DePuy Synthes	accessdata.fda.gov
December 21, 2018	K180821	TruMatch Graft Cage - Long Bone	HRS	Substantially Equivalent	Synthes (Usa), LLC	accessdata.fda.gov
December 6, 2018	K181231	DePuy Synthes T-PAL Spacer System	MAX	Substantially Equivalent	Depuy Synthes Spine	accessdata.fda.gov
November 21, 2018	K180541	DePuy Synthes 2.0 mm Quick Insertion Screws	HWC	Substantially Equivalent	Synthes USA Products, LLC	accessdata.fda.gov
October 4, 2018	K181949	SYMPHONY OCT System	NKG	Substantially Equivalent	Medos International SARL	accessdata.fda.gov
September 21, 2018	K173960	DePuy Corail AMT Hip Prosthesis	LZO	Substantially Equivalent	Depuy France S.A.S.	accessdata.fda.gov
August 3, 2018	K181809	GRYPHON® Anchors with DYNACORD Suture	MAI	Substantially Equivalent	Medos International SARL	accessdata.fda.gov
August 2, 2018	K181182	DYNACORD Suture	GAT	Substantially Equivalent	Medos International SARL	accessdata.fda.gov
June 11, 2018	K173787	X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System, Surgical Titanium Mesh System, BENGAL Stackable Cage System, BENGAL System, CONCORDE® System, CONCORDE® Inline Lumbar Interbody System, CONCORDE® Curve Lumbar Interbody System, CONCORDE® Bullet Lumbar Interbody System, COUGAR® System, COUGAR® LS Lateral Cage System, DEVEX® System, LEOPARD® System, DePuy PULSE Cervical Cage System, DePuy PULSE Lumbar Cage System, LUMBAR I/F CAGE® System	MQP	Substantially Equivalent	Medos International SARL	accessdata.fda.gov
April 26, 2018	K170339	Summit Hip System	LZO	Substantially Equivalent	DePuy Orthopaedics, Inc.	accessdata.fda.gov
April 11, 2018	K173859	HEALIX ADVANCE Anchor with DYNACORD Suture	MAI	Substantially Equivalent	Medos International SARL	accessdata.fda.gov
April 5, 2018	K173526	SENTIO MMG Gen 2	PDQ	Substantially Equivalent	Medos International SARL	accessdata.fda.gov
March 5, 2018	K172872	DePuy Synthes Femoral Neck System	KTT	Substantially Equivalent	DePuy Synthes	accessdata.fda.gov
January 11, 2018	K170748	GLOBAL UNITE Platform Shoulder System	PHX	Substantially Equivalent	Depuy Ireland UC	accessdata.fda.gov
December 7, 2017	K170818	Craniomaxillofacial Distraction System (CMFD)	PBJ	Substantially Equivalent	Synthes USA Products, LLC	accessdata.fda.gov
November 14, 2017	K172157	DePuy Synthes Femoral Recon Nail System	HSB	Substantially Equivalent	Synthes (USA) Products, LLC	accessdata.fda.gov
October 25, 2017	K173095	VIPER PRIME Screws, VIPER PRIME Screws with Fenestrations, EXPEDIUM® Verse Screws with Fenestrations	NKB	Substantially Equivalent	Medos International SARL	accessdata.fda.gov
September 28, 2017	K170802	TRAUMACEM V+ Injectable Bone Cement	LOD	Substantially Equivalent	Synthes (USA) Products, LLC	accessdata.fda.gov
September 14, 2017	K170937	VIPER PRIME navigated inserter	OLO	Substantially Equivalent	Medos International SARL	accessdata.fda.gov
August 31, 2017	K171570	Additional VIPER PRIME screws with fenestrations	NKB	Substantially Equivalent	Medos International SARL	accessdata.fda.gov
July 20, 2017	K171439	EAGLE Plus Anterior Cervical Plate System, EAGLE Plus Micro Anterior Cervical Plate System, PULSE Anterior Cervical Plate System, SKYLINE Anterior Cervical Plate System, SLIM LOC Anterior Cervical Plate System, SWIFT Plus Anterior Cervical Plate System, UNIPLATE Anterior Cervical Plate System, UNIPLATE 2 Anterior Cervical Plate System	KWQ	Substantially Equivalent	Medos International SARL	accessdata.fda.gov
June 30, 2017	K171284	FIBERGRAFT BG Matrix Bone Graft Substitute	MQV	Substantially Equivalent	Prosidyan, Inc.	accessdata.fda.gov
June 30, 2017	K160553	DePuy Synthes 4.0 mm and 5.0 mm Locking Screws MR Conditional, DePuy Synthes Wrist Fusion Plate (WFP) MR Conditional, DePuy Synthes Large Fragment Dynamic Compression Locking (DCL) System MR Conditional, DePuy Synthes Small Fragment Dynamic Compression Locking (DCL) System MR Conditional, DePuy Synthes Modular Foot System MR Conditional, DePuy Synthes T-Plates MR Conditional, DePuy Synthes One-third Tubular Plate with Collar (OTPC) MR Conditional, DePuy Synthes Stainless S	HRS	Substantially Equivalent	Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.	accessdata.fda.gov
June 15, 2017	K170806	ATTUNE Cemented Tibial Base, Fixed Bearing	JWH	Substantially Equivalent	Depuy(Ireland)	accessdata.fda.gov
May 24, 2017	K170306	FIBERGRAFT BG Putty Bone Graft Substitute	MQV	Substantially Equivalent	Prosidyan, Inc.	accessdata.fda.gov
May 8, 2017	K162594	Craniomaxillofacial Distraction System (CMFD)	MQN	Substantially Equivalent	Synthes USA Products, LLC	accessdata.fda.gov
May 4, 2017	K170543	VIPER PRIME Screws with Fenestrations	NKB	Substantially Equivalent	Medos International SARL	accessdata.fda.gov
March 29, 2017	K162124	Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension, Variable Angle Positioning Pins	JDP	Substantially Equivalent	DePuy Synthes	accessdata.fda.gov
February 16, 2017	K161616	DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws, DePuy Synthes 3.5 mm and 4.0 mm Cannulated Screws, DePuy Synthes 4.5 mm Cannulated Screws, DePuy Synthes 6.5 mm Cannulated Screws, DePuy Synthes 7.0 mm and 7.3 mm Cannulated Screws, DePuy Synthes 1.5 mm Headless Compression Screws, DePuy Synthes 2.4 mm Headless Compression Screws, DePuy Synthes 3.0 mm Headless Compression Screws, DePuy Synthes 4.5 mm and 6.5 mm Headless Compression Screw	HWC	Substantially Equivalent	Synthes USA Products, LLC	accessdata.fda.gov
February 9, 2017	K163046	DePuy Synthes 2.4/2.7mm VA LCP Two-Column Volar Distal Radius Plate, Extra-Long	HRS	Substantially Equivalent	DePuy Synthes	accessdata.fda.gov
January 18, 2017	K153587	Taps for Resorbable Screws	HBG	Substantially Equivalent	Synthes (USA) Products, LLC	accessdata.fda.gov
December 20, 2016	K160879	CONFIDENCE High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw Systems	PML	Substantially Equivalent	Medos International Sàrl	accessdata.fda.gov
December 8, 2016	K162912	VIPER PRIME additions to the VIPER® System	NKB	Substantially Equivalent	Medos International SARL	accessdata.fda.gov
November 10, 2016	K161417	DePuy Synthes MAXFRAME Multi-Axial Correction System	KTT	Substantially Equivalent	Synthes USA, LLC	accessdata.fda.gov
November 7, 2016	K161638	SPEEDTRAP Graft Preparation System	GAT	Substantially Equivalent	Medos International SARL	accessdata.fda.gov
November 3, 2016	K161590	MatrixRIB Fixation System	HRS	Substantially Equivalent	Synthes (USA) Products, LLC	accessdata.fda.gov
September 26, 2016	K160167	DePuy Synthes TFNA Augmentation System	HSB	Substantially Equivalent	Synthes (USA) Products, LLC	accessdata.fda.gov
August 1, 2016	K160856	SpineView X-Pac Expandable Lumbar Cage System	MAX	Substantially Equivalent	Spine View, Inc.	accessdata.fda.gov
July 19, 2016	K160907	DePuy Actis DuoFix Hip Prosthesis	MEH	Substantially Equivalent	Depuy(Ireland)	accessdata.fda.gov
July 19, 2016	K160804	INTRAFIX(TM) Advance Tibial Fastener System	MAI	Substantially Equivalent	Medos International SARL	accessdata.fda.gov
July 1, 2016	K160904	Expedium Spine System, VIPER and VIPER 2 Systems	NKB	Substantially Equivalent	Medos International SARL	accessdata.fda.gov
June 10, 2016	K160700	ATTUNE Revision Knee System	JWH	Substantially Equivalent	Depuy(Ireland)	accessdata.fda.gov
June 9, 2016	K161001	MILAGRO ADVANCE PEEK Interference Screw	MBI	Substantially Equivalent	Medos International SARL	accessdata.fda.gov
March 24, 2016	K153667	TRUESPAN Meniscal Repair System	MBI	Substantially Equivalent	Medos International SARL	accessdata.fda.gov
February 26, 2016	K153575	Tyber Medical Trauma Screw	HWC	Substantially Equivalent	Tyber Medical, LLC	accessdata.fda.gov
February 24, 2016	K152539	SpineView X-Pac Expandable Lumbar Cage System	MAX	Substantially Equivalent	Spine View, Inc.	accessdata.fda.gov
December 2, 2015	K152239	Zero-P Natural Plate System	KWQ	Substantially Equivalent	Synthes (Usa), LLC	accessdata.fda.gov
November 20, 2015	K151773	CONCORDE Bullet Lumbar Interbody System	MAX	Substantially Equivalent	Medos International SARL	accessdata.fda.gov
November 17, 2015	K151004	PULLUP® Adjustable Juxtacortical Fixation Device	MBI	Substantially Equivalent	Sbm Sciences For Bio Materials	accessdata.fda.gov
November 10, 2015	K151154	FIBERGRAFT BG Morsels	MQV	Substantially Equivalent	Prosidyan, Inc.	accessdata.fda.gov
October 8, 2015	K151352	CONCORDE Bullet Spinal System	MAX	Substantially Equivalent	Medos International SARL	accessdata.fda.gov
October 6, 2015	K150209	Healix BR Anchor, Healix PEEK Anchor, Healix Transtend, Gryphon T and P BR Anchor, Gryphon PEEK Anchor, VersaLok Anchor, Bioknotless BR Anchor, Lupine BR Anchor, PanaLok Anchor,PanaLok Anchor with Orthocord, PanaLok RC QuickAnchor Plus; PanaLok RC QuickAnchor Plus Dual Suture, PanaLok RC QuickAnchor Plus w/Orthocord; PanaLok RC QuickAnchor Plus Dual Suture w/Orthocord, PanaLok Loop Anchor, Lupine Loop Anchor, PanaLok RC Lop Anchor, BioKnotless Anchor, BioKnotless RC Anchor, RC Loop Anc	MAI	Substantially Equivalent	Depuy Mitek, A Johnson and Johnson Company	accessdata.fda.gov
September 25, 2015	K150862	DePuy Actis Duofox Hip Prosthesis	MEH	Substantially Equivalent	DePuy Orthopaedics, Inc.	accessdata.fda.gov
September 3, 2015	K151885	SUMMIT SI OCT Spinal Fixation System, MOUNTAINEER OCT Spinal System	NKG	Substantially Equivalent	Depuy Synthes, Inc.	accessdata.fda.gov
August 21, 2015	K150673	SYNFIX Evolution Secured Spacer System	OVD	Substantially Equivalent	Synthes (USA) Products, LLC	accessdata.fda.gov
June 23, 2015	K150796	Dental Bone Cutting Instruments	DZJ	Substantially Equivalent	Synthes (USA) Products, LLC	accessdata.fda.gov
June 18, 2015	K151276	DePuy Synthes T-PAL Ti Spacer	MAX	Substantially Equivalent	Synthes USA Products, LLC	accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

Approved	PMA number	Device	Product code	Supplements	Latest decision	Source
April 12, 1985	P830055	LCS(R) TOTAL KNEE SYSTEM	NJL	355	October 9, 2026	accessdata.fda.gov

Compare with other makers

Updated October 9, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.