Data / Medical devices / Netherlands / Arthrex Distribution Hub EMEA B.V.

Arthrex Distribution Hub EMEA B.V.: FDA-registered device maker in Venlo Limburg, Netherlands, 255 510(k) clearances

Name: Arthrex Distribution Hub EMEA B.V. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Arthrex Distribution Hub EMEA B.V. is registered with the FDA (registration 3016851379) in Venlo Limburg, Netherlands. It lists 83 device types. The FDA files 255 510(k) clearances under its listings, the newest dated July 25, 2024. Registered through 2027. FDA data exported November 3, 2026.

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FDA registration number: 3016851379
Address: Amperestraat 9, Venlo Limburg, Netherlands, 5928 PE
Owner or operator: ARTHREX, INC. (1220287)
Roles: Exporter to the US
First device listed: January 27, 1994
Registered through: 2027
Brand names listed: ACCIN Bipolar Head System, ACCIN Patellofemoral System, ACCIN Total Knee System, ACCIN Uni-Knee System, ACL TightRope, ACL TightRope Double Bundle, AESCULAP STERILCONTAINER SYSTEM, ANATOEMIC PROSTHESIS and more

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Arthroscopic	NBH	1	Exporter to the US	accessdata.fda.gov
Adaptor, Holder, Syringe	IQG	1	Exporter to the US	accessdata.fda.gov
Apparatus, Traction, Non-Powered	HST	1	Exporter to the US	accessdata.fda.gov
Arthroscope	HRX	2	Exporter to the US	accessdata.fda.gov
Balance, Analytical	JQO	1	Exporter to the US	accessdata.fda.gov
Bit, Drill	HTW	1	Exporter to the US	accessdata.fda.gov
Blade, Saw, General & Plastic Surgery, Surgical	GFA	1	Exporter to the US	accessdata.fda.gov
Bone Wedge	PLF	2	Exporter to the US	accessdata.fda.gov
Bur, Surgical, General & Plastic Surgery	GFF	1	Exporter to the US	accessdata.fda.gov
Camera, Cine, Endoscopic, Without Audio	FWL	1	Exporter to the US	accessdata.fda.gov
Camera, Surgical And Accessories	KQM	1	Exporter to the US	accessdata.fda.gov
Camera, Television, Surgical, Without Audio	FWB	1	Exporter to the US	accessdata.fda.gov
Cart, Emergency, Cardiopulmonary (Excluding Equipment)	BZN	1	Exporter to the US	accessdata.fda.gov
Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use	JQC	1	Exporter to the US	accessdata.fda.gov
Cerclage, Fixation	JDQ	2	Exporter to the US	accessdata.fda.gov
Clamp	HXD	1	Exporter to the US	accessdata.fda.gov
Component, Traction, Non-Invasive	KQZ	1	Exporter to the US	accessdata.fda.gov
Display, Cathode-Ray Tube, Medical	DXJ	2	Exporter to the US	accessdata.fda.gov
Dressing, Compression	MHW	1	Exporter to the US	accessdata.fda.gov
Dressing, Wound, Drug	FRO	U	Exporter to the US	accessdata.fda.gov
Dressing, Wound, Hydrophilic	NAC	1	Exporter to the US	accessdata.fda.gov
Electrosurgical, Cutting & Coagulation & Accessories	GEI	2	Exporter to the US	accessdata.fda.gov
Expander, Surgical, Skin Graft	FZW	1	Exporter to the US	accessdata.fda.gov
Fastener, Fixation, Biodegradable, Soft Tissue	MAI	2	Exporter to the US	accessdata.fda.gov
Fastener, Fixation, Nondegradable, Soft Tissue	MBI	2	Exporter to the US	accessdata.fda.gov
Filler, Bone Void, Calcium Compound	MQV	2	Exporter to the US	accessdata.fda.gov
Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)	MBP	2	Exporter to the US	accessdata.fda.gov
Finger Cot	LZB	1	Exporter to the US	accessdata.fda.gov
Forceps	HTD	1	Exporter to the US	accessdata.fda.gov
Gauge, Depth	HTJ	1	Exporter to the US	accessdata.fda.gov
Goniometer, Ac-Powered	KQX	1	Exporter to the US	accessdata.fda.gov
Guide, Drill, Ligament	LXI	1	Exporter to the US	accessdata.fda.gov
Instrument, Cutting, Orthopedic	HTZ	1	Exporter to the US	accessdata.fda.gov
Instrument, Manual, Surgical, General Use	MDM	1	Exporter to the US	accessdata.fda.gov
Instrument, Special Lens, For Endoscope	FEI	1	Exporter to the US	accessdata.fda.gov
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	HWE	1	Exporter to the US	accessdata.fda.gov
Laparoscope, General & Plastic Surgery	GCJ	2	Exporter to the US	accessdata.fda.gov
Medical Device Data System	OUG	1	Exporter to the US	accessdata.fda.gov
Needle, Suturing, Disposable	GAB	1	Exporter to the US	accessdata.fda.gov
Operating Room Accessories Table Tray	FWZ	1	Exporter to the US	accessdata.fda.gov
Orthopedic Manual Surgical Instrument	LXH	1	Exporter to the US	accessdata.fda.gov
Pin, Fixation, Smooth	HTY	2	Exporter to the US	accessdata.fda.gov
Plate, Fixation, Bone	HRS	2	Exporter to the US	accessdata.fda.gov
Platelet And Plasma Separator For Bone Graft Handling	ORG	2	Exporter to the US	accessdata.fda.gov
Probe	HXB	1	Exporter to the US	accessdata.fda.gov
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	KWY	2	Exporter to the US	accessdata.fda.gov
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	JDI	2	Exporter to the US	accessdata.fda.gov
Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer	HSX	2	Exporter to the US	accessdata.fda.gov
Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer	KRR	2	Exporter to the US	accessdata.fda.gov
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	MBH	2	Exporter to the US	accessdata.fda.gov
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive	OIY	2	Exporter to the US	accessdata.fda.gov
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	JWH	2	Exporter to the US	accessdata.fda.gov
Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	HSD	2	Exporter to the US	accessdata.fda.gov
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	KWS	2	Exporter to the US	accessdata.fda.gov
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented	MBF	2	Exporter to the US	accessdata.fda.gov
Prosthesis, Toe, Hemi-, Phalangeal	KWD	2	Exporter to the US	accessdata.fda.gov
Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained	PKC	2	Exporter to the US	accessdata.fda.gov
Punch, Surgical	LRY	1	Exporter to the US	accessdata.fda.gov
Reamer	HTO	1	Exporter to the US	accessdata.fda.gov
Retention Device, Suture	KGS	1	Exporter to the US	accessdata.fda.gov
Rod, Fixation, Intramedullary And Accessories	HSB	2	Exporter to the US	accessdata.fda.gov
Saw, Powered, And Accessories	HAB	1	Exporter to the US	accessdata.fda.gov
Screw, Fixation, Bone	HWC	2	Exporter to the US	accessdata.fda.gov
Shoulder Arthroplasty Implantation System	QHE	2	Exporter to the US	accessdata.fda.gov
Shoulder Prosthesis, Reverse Configuration	PHX	2	Exporter to the US	accessdata.fda.gov
Staple Driver	HXJ	1	Exporter to the US	accessdata.fda.gov
Staple, Absorbable	MNU	2	Exporter to the US	accessdata.fda.gov
Staple, Fixation, Bone	JDR	2	Exporter to the US	accessdata.fda.gov
Sterilizer, Steam	FLE	2	Exporter to the US	accessdata.fda.gov
Suture, Nonabsorbable, Silk	GAP	2	Exporter to the US	accessdata.fda.gov
Suture, Nonabsorbable, Synthetic, Polyester	GAS	2	Exporter to the US	accessdata.fda.gov
Suture, Nonabsorbable, Synthetic, Polyethylene	GAT	2	Exporter to the US	accessdata.fda.gov
Syringe, Irrigating (Non Dental)	KYZ	1	Exporter to the US	accessdata.fda.gov
Syringe, Piston	FMF	2	Exporter to the US	accessdata.fda.gov
System, Image Processing, Radiological	LLZ	2	Exporter to the US	accessdata.fda.gov
System, X-Ray, Angiographic	IZI	2	Exporter to the US	accessdata.fda.gov
Table And Attachments, Operating-Room	BWN	1	Exporter to the US	accessdata.fda.gov
Template	HWT	1	Exporter to the US	accessdata.fda.gov
Total Shoulder Arthroplasty System	QHQ	2	Exporter to the US	accessdata.fda.gov
Tray, Surgical, Instrument	FSM	1	Exporter to the US	accessdata.fda.gov
Tubing, Noninvasive	GAZ	2	Exporter to the US	accessdata.fda.gov
Washer, Bolt Nut	HTN	2	Exporter to the US	accessdata.fda.gov
Wrap, Sterilization	FRG	2	Exporter to the US	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 255.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
July 25, 2024	K241361	Arthrex Synergy Vision Endoscopic Imaging System	GCJ	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
May 29, 2024	K241235	Arthrex TightRope II	MBI	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
November 15, 2023	K232973	Arthrex Knee FiberTak® Button Suture Anchor	MBI	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
October 6, 2023	K232755	Arthrex FiberTape and TigerTape Cerclage Sutures	HTN	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
September 1, 2023	K232340	Arthrex 2.4mm Knotless Hip SutureTak® Suture Anchor	MBI	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
August 8, 2023	K231857	Arthrex TightRope II	MBI	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
June 22, 2023	K230904	Arthrex Virtual Implant Positioning (VIP) System	QHE	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
May 18, 2023	K231113	Arthrex FiberTak Suture Anchor	MBI	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
February 24, 2023	K223759	Arthrex SynergyID Endoscopic Imaging System	GCJ	Substantially Equivalent	Arthex, Inc.	accessdata.fda.gov
December 22, 2022	K221396	Arthrex FiberTak Suture Anchor	MBI	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
October 3, 2022	K222267	Arthrex 2.4 mm Volar Distal Radius Plate System	HRS	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
September 30, 2022	K222244	Arthrex 3.5 mm Locking Compression Plates	HRS	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
September 19, 2022	K220839	Arthrex Compression FT Pins	HWC	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
September 14, 2022	K222078	Arthrex SoftStitch	GAT	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
September 9, 2022	K221354	Arthrex SutureTape	GAT	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
August 26, 2022	K222263	Arthrex Self Punching SwiveLock Suture Anchors	MAI	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
August 22, 2022	K221485	Arthrex FiberTape and TigerTape Cerclage Sutures	HTN	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
August 11, 2022	K222161	Arthrex Knotless FiberTak Biceps Suture Anchor	MBI	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
June 29, 2022	K220937	Arthrex Mini Fragment System	HRS	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
June 6, 2022	K220947	Arthrex Knotless AC Repair Devices	HTN	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
May 13, 2022	K221099	Arthrex Self-Punching PushLock Suture Anchor	MAI	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
May 2, 2022	K213837	Arthrx Fracture Plates	HRS	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
December 17, 2021	K213644	Arthrex Knotless Mini TightRopes	HTN	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
June 1, 2021	K210994	Arthrex Beveled FT Screws	HWC	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
April 19, 2021	K203495	Arthrex SwiveLock Anchor	MAI	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
March 25, 2021	K203834	Arthrex Patella SuturePlates	HRS	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
February 3, 2021	K203294	Arthrex Pilon Fusion System	HRS	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
December 30, 2020	K203239	Arthrex Low Profile Screws	HWC	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
December 16, 2020	K203180	Arthrex DynaNite Nitinol Staples	JDR	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
November 27, 2020	K203268	Arthrex FiberTak Suture Anchor	MBI	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
November 20, 2020	K203100	Arthrex Eclipse Titanium Humeral Head	PKC	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
November 18, 2020	K202535	Arthrex FastThread Interference Screw	MAI	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
November 17, 2020	K202444	Knotless TensionTight Button Implant System	MBI	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
November 4, 2020	K202581	Arthrex TightRope II	MBI	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
October 2, 2020	K190707	Arthrex SoftStitch	GAT	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
September 4, 2020	K201134	Arthrex NanoScope System	GCJ	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
September 3, 2020	K201522	Arthrex Syndesmosis TightRope XP Buttress Plate Implant System	HTN	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
September 2, 2020	K201677	Arthrex Mesh Plates	HRS	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
August 21, 2020	K201749	Arthrex SwiveLock Anchor	MAI	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
August 13, 2020	K200895	Univers Revers Modular Glenoid System, Half Augment Baseplate	PHX	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
July 30, 2020	K201786	Arthrex Mini Hip PushLock	MAI	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
July 27, 2020	K201132	Arthrex Compression Screws	HRS	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
July 24, 2020	K193575	Arthrex SutureTape	GAT	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
July 8, 2020	K201542	Arthrex Eclipse Shoulder Prosthesis System	PKC	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
July 8, 2020	K193345	Arthrex DynaNite Compression Plate	HRS	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
July 6, 2020	K201235	Arthrex MaxForce MTP Compression Plates and Screws	HRS	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
June 29, 2020	K200068	Arthrex DynaNite K-Wire	HTY	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
April 30, 2020	K193523	ArthrexVIP Web Portal	LLZ	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
March 17, 2020	K200433	iBalance UKA Tibial Tray Implant	HSX	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
March 12, 2020	K200341	Arthrex FiberTak Suture Anchor	MBI	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
February 10, 2020	K193156	Arthrex Mini Comprehensive Fixation System - 1.0mm Screws	HWC	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
January 15, 2020	K193503	Arthrex SwiveLock Suture Anchor	MAI	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
January 10, 2020	K193372	Univers Revers Modular Glenoid System (Augemented baseplates)	PHX	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
December 23, 2019	K191960	Arthrex Univers Revers Modular Glenoid System	PHX	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
December 12, 2019	K193157	Arthrex 3.9mm Corkscrew Suture Anchor	MAI	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
November 26, 2019	K191426	FiberTak Button	MBI	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
November 6, 2019	K191651	Arthrex Nano SwiveLock Suture Anchor	HWC	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
October 30, 2019	K190921	Arthrex Low Profile Screws	HWC	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
October 19, 2019	K192532	Arthrex SwiveLock Anchor	MAI	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
October 17, 2019	K192441	Arthrex SwiveLock Anchors	MAI	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
October 16, 2019	K190953	Arthrex Minimally Invasive Ankle Fusion Plate	HRS	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
October 15, 2019	K191326	Arthrex Mini Comprehensive Fixation System 1.4mm & 1.6mm Module	HRS	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
October 3, 2019	K191344	Arthrex Mini Comprehensive Fixation System 2.0mm & 2.4mm Module	HRS	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
September 13, 2019	K190288	Arthrex Tenodesis Button	MBI	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
July 26, 2019	K183194	Arthrex Eclipse Shoulder Prosthesis System	QHQ	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
July 5, 2019	K190645	Arthrex NanoScope System	GCJ	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
June 11, 2019	K191226	Arthrex SwiveLock Suture Anchor	MAI	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
May 19, 2019	K190125	FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch Implant, Straight with two Polyester Implants and 2-0 FiberWire	MBI	Substantially Equivalent	T.A.G. Medical Products Corporation, Ltd.	accessdata.fda.gov
May 3, 2019	K190287	Arthrex DynaNite® PIP (Hammertoe) Implant	HTY	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
April 17, 2019	K183395	Arthrex 2.5 mm Tenodesis Screw	HWC	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
March 26, 2019	K183628	Arthrex TensionLoc System	HWC	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
March 8, 2019	K182799	Arthrex Univers II Shoulder Prosthesis System: Titanium Humeral Heads	KWS	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
December 21, 2018	K181555	Arthrex Fracture Adapter Hemi Shoulder Prosthesis	KWS	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
December 18, 2018	K182361	Arthrex Compression FT Screws	HWC	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
December 14, 2018	K180768	Arthrex SwiveLock Anchors	MAI	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
September 28, 2018	K182039	Arthrex Univers Revers Porous Coated Baseplate and Universal Glenoid Inlay	PHX	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
September 21, 2018	K181769	Arthrex FiberTak Suture Anchor	MBI	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
August 30, 2018	K181513	Arthrex PushLock Tenodesis Anchor	MBI	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
August 6, 2018	K173845	Arthrex SwiveLock	MBI	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
July 26, 2018	K173656	Arthrex FibuLock Nail	HSB	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
June 22, 2018	K180594	Knotless SutureTak Anchors	MAI	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
May 22, 2018	K180662	Arthrex FastThread Interference Screw	MAI	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
April 20, 2018	K173900	Arthrex Univers Revers Modular Glenoid System	PHX	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
March 29, 2018	K171841	Arthrex Shoulder System	KWS	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
March 22, 2018	K172371	Arthrex UNIVERS REVERS COATED BASEPLATE	PHX	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
March 1, 2018	K173788	Arthrex Corkscrew FT	MAI	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
February 23, 2018	K171869	Sutter CURIS RF Generator	GEI	Substantially Equivalent	Sutter Medizintechnik GmbH	accessdata.fda.gov
February 22, 2018	K173381	Nexxis OR	DXJ	Substantially Equivalent	Barco N.V.	accessdata.fda.gov
February 12, 2018	K180118	Arthrex NanoSuture Anchor	MBI	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
January 16, 2018	K173240	Arthrex PushLock	MAI	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
December 14, 2017	K170414	Arthrex Univers Revers Apex Humeral Stems	PHX	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
December 13, 2017	K172052	Arthrex DynaNite Nitinol Staple	JDR	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
November 15, 2017	K170206	Arthrex FiberTape Cerclage	JDQ	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
November 7, 2017	K171365	Arthrex Knee Systems	MBH	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
September 28, 2017	K172612	FiberTak DX	MBI	Substantially Equivalent	Arthex, Inc.	accessdata.fda.gov
September 1, 2017	K170547	Arthrex Mesh Plate System	HRS	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
May 26, 2017	K171296	SutureTape	GAT	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
May 16, 2017	K171020	Arthrex Knotless SutureTak Anchor	MBI	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
May 11, 2017	K170382	Arthrex Compression Screws	HWC	Substantially Equivalent	Arthrex, Inc.	accessdata.fda.gov
February 24, 2017	K161371	Sonoma Fifth Metatarsal Repair System	HSB	Substantially Equivalent	Sonoma Orthopedic Products, Inc.	accessdata.fda.gov

Compare with other makers

Updated July 25, 2024. 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.