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Data / Medical devices / Switzerland / Medos International Sarl

Medos International Sarl: FDA-registered device maker in Le Locle Neuchatel, Switzerland, 323 510(k) clearances and 1 PMA approval

Medos International Sarl is registered with the FDA (registration 3008114965) in Le Locle Neuchatel, Switzerland. It lists 139 device types. The FDA files 323 510(k) clearances and 1 PMA approval under its listings, the newest dated May 26, 2026. 2 recall events name it as the recalling firm (1 Class I). Registered through 2027. FDA data exported November 2, 2026.

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Get makers like this oneWatch Medos International Sarl
FDA registration number
3008114965
Address
Chemin-Blanc 38, Le Locle Neuchatel, Switzerland, 2400
Owner or operator
Medos International SARL (10031083)
Roles
Specification developer
First device listed
December 16, 2009
Registered through
2027
Brand names listed
ABSOLUTE, ACL GRAFT KNIVES, ACORN, AEGIS Anterior Lumbar Plate System, AETI System, ALC, ALC Dynamized Fixation System, ARTHROSCOPE (MULTIPLE BRANDS) and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessories, ArthroscopicNBH1Specification developeraccessdata.fda.gov
Accessories, Photographic, For Endoscope (Exclude Light Sources)FEM1Specification developeraccessdata.fda.gov
Anchor, Suture, Bone Fixation, MetallicNOV2Specification developeraccessdata.fda.gov
Apparatus, Suction, Operating-Room, Wall Vacuum PoweredGCX2Specification developeraccessdata.fda.gov
Appliance, Fixation, Spinal InterlaminalKWP2Specification developeraccessdata.fda.gov
Appliance, Fixation, Spinal Intervertebral BodyKWQ2Specification developeraccessdata.fda.gov
Applier, Staple, Surgical,GEF1Specification developeraccessdata.fda.gov
ArthroscopeHRX2Specification developeraccessdata.fda.gov
AwlHWJ1Specification developeraccessdata.fda.gov
BenderHXW1Specification developeraccessdata.fda.gov
Bit, DrillHTW1Specification developeraccessdata.fda.gov
Bit, SurgicalGFG1Specification developeraccessdata.fda.gov
Bone Cement, Posterior Screw AugmentationPML2Specification developeraccessdata.fda.gov
Bone Grafting Material, SyntheticLYC2Specification developeraccessdata.fda.gov
BroachHTQ1Specification developeraccessdata.fda.gov
CaliperKTZ1Specification developeraccessdata.fda.gov
Camera, Surgical And AccessoriesKQM1Specification developeraccessdata.fda.gov
Camera, Television, Endoscopic, Without AudioFWF1Specification developeraccessdata.fda.gov
Cannula, Surgical, General & Plastic SurgeryGEA1Specification developeraccessdata.fda.gov
Cart, Emergency, Cardiopulmonary (Excluding Equipment)BZN1Specification developeraccessdata.fda.gov
Catheter And Tip, SuctionJOL2Specification developeraccessdata.fda.gov
Catheter, Continuous FlushKRA2Specification developeraccessdata.fda.gov
Catheter, Intravascular Occluding, TemporaryMJN2Specification developeraccessdata.fda.gov
Catheter, Intravascular, DiagnosticDQO2Specification developeraccessdata.fda.gov
Catheter, PercutaneousDQY2Specification developeraccessdata.fda.gov
Catheter, Percutaneous, NeurovasculatureQJP2Specification developeraccessdata.fda.gov
Catheter, Thrombus RetrieverNRY2Specification developeraccessdata.fda.gov
Cement, Bone, VertebroplastyNDN2Specification developeraccessdata.fda.gov
Cerclage, FixationJDQ2Specification developeraccessdata.fda.gov
Chisel, Surgical, ManualFZO1Specification developeraccessdata.fda.gov
Component, Traction, InvasiveJEC2Specification developeraccessdata.fda.gov
CuretteHTF1Specification developeraccessdata.fda.gov
Cutter, SurgicalFZT1Specification developeraccessdata.fda.gov
Depressor, OrbitalHNX1Specification developeraccessdata.fda.gov
Device, Monitoring, Intracranial PressureGWM2Specification developeraccessdata.fda.gov
Device, Neurovascular EmbolizationHCG2Specification developeraccessdata.fda.gov
Device, Percutaneous, BiopsyMJG1Specification developeraccessdata.fda.gov
Device, Vascular, For Promoting EmbolizationKRD2Specification developeraccessdata.fda.gov
Disinfectant, Medical DevicesLRJ1Specification developeraccessdata.fda.gov
Dispenser, CementKIH1Specification developeraccessdata.fda.gov
Dissector, Surgical, General & Plastic SurgeryGDI1Specification developeraccessdata.fda.gov
Driver, ProsthesisHWR1Specification developeraccessdata.fda.gov
Electrosurgical, Cutting & Coagulation & AccessoriesGEI2Specification developeraccessdata.fda.gov
ElevatorHTE1Specification developeraccessdata.fda.gov
Elevator, Surgical, General & Plastic SurgeryGEG1Specification developeraccessdata.fda.gov
ExtractorHWB1Specification developeraccessdata.fda.gov
Fastener, Fixation, Biodegradable, Soft TissueMAI2Specification developeraccessdata.fda.gov
Fastener, Fixation, Nondegradable, Soft TissueMBI2Specification developeraccessdata.fda.gov
Filler, Bone Void, Calcium CompoundMQV2Specification developeraccessdata.fda.gov
ForcepsHTD1Specification developeraccessdata.fda.gov
Gauge, DepthHTJ1Specification developeraccessdata.fda.gov
Growing Rod SystemPGM2Specification developeraccessdata.fda.gov
Guide, Needle, SurgicalGDF1Specification developeraccessdata.fda.gov
Guide, Surgical, InstrumentFZX1Specification developeraccessdata.fda.gov
Guide, Wire, Catheter, NeurovasculatureMOF2Specification developeraccessdata.fda.gov
Hammer, SurgicalFZY1Specification developeraccessdata.fda.gov
Handle, ScalpelGDZ1Specification developeraccessdata.fda.gov
Holder, Needle; OrthopedicHXK1Specification developeraccessdata.fda.gov
Hook, Surgical, General & Plastic SurgeryGDG1Specification developeraccessdata.fda.gov
ImpactorHWA1Specification developeraccessdata.fda.gov
Implant, Fixation Device, SpinalJDN2Specification developeraccessdata.fda.gov
Injector, Vertebroplasty (Does Not Contain Cement)OAR1Specification developeraccessdata.fda.gov
Instrument, CompressionHWN1Specification developeraccessdata.fda.gov
Instrument, Cutting, OrthopedicHTZ1Specification developeraccessdata.fda.gov
Instrument, Ligature Passing And Knot TyingHCF1Specification developeraccessdata.fda.gov
Instrument, Manual, Surgical, General UseMDM1Specification developeraccessdata.fda.gov
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/AttachmentHWE1Specification developeraccessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, CervicalODP2Specification developeraccessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, LumbarMAX2Specification developeraccessdata.fda.gov
Intervertebral Fusion Device With Integrated Fixation, LumbarOVD2Specification developeraccessdata.fda.gov
Intracranial Neurovascular StentNJEfSpecification developeraccessdata.fda.gov
Introducer, CatheterDYB2Specification developeraccessdata.fda.gov
Kit, Surgical Instrument, DisposableKDD1Specification developeraccessdata.fda.gov
Knife, OrthopedicHTS1Specification developeraccessdata.fda.gov
Laparoscope, General & Plastic SurgeryGCJ2Specification developeraccessdata.fda.gov
Lavage, JetFQH2Specification developeraccessdata.fda.gov
Light Source, Fiberoptic, RoutineFCW2Specification developeraccessdata.fda.gov
Light, Surgical, ConnectorFSX2Specification developeraccessdata.fda.gov
Light, Surgical, FiberopticFST2Specification developeraccessdata.fda.gov
Mesh, Surgical, MetalEZX2Specification developeraccessdata.fda.gov
Mixer, Cement, For Clinical UseJDZ1Specification developeraccessdata.fda.gov
Nasopharyngoscope (Flexible Or Rigid)EOB2Specification developeraccessdata.fda.gov
Needle, Aspiration And Injection, DisposableGAA1Specification developeraccessdata.fda.gov
Needle, Suturing, DisposableGAB1Specification developeraccessdata.fda.gov
Neurological Stereotaxic InstrumentHAW2Specification developeraccessdata.fda.gov
Neurosurgical Nerve LocatorPDQ2Specification developeraccessdata.fda.gov
Neurovascular Liquid Embolic AgentSGU3Specification developeraccessdata.fda.gov
Orthopedic Manual Surgical InstrumentLXH1Specification developeraccessdata.fda.gov
Orthopedic Stereotaxic InstrumentOLO2Specification developeraccessdata.fda.gov
Orthosis, CervicalIQK1Specification developeraccessdata.fda.gov
Orthosis, Spinal Pedicle FixationMNI2Specification developeraccessdata.fda.gov
Orthosis, Spine, Plate, Laminoplasty, MetalNQW2Specification developeraccessdata.fda.gov
Orthosis, Spondylolisthesis Spinal FixationMNH2Specification developeraccessdata.fda.gov
OsteotomeHWM1Specification developeraccessdata.fda.gov
Pedicle Screw Spinal System, Adolescent Idiopathic ScoliosisOSH2Specification developeraccessdata.fda.gov
Peripheral Mechanical Thrombectomy With AspirationQEW2Specification developeraccessdata.fda.gov
Pin, Fixation, SmoothHTY2Specification developeraccessdata.fda.gov
Pin, Fixation, ThreadedJDW2Specification developeraccessdata.fda.gov
Plate, Fixation, BoneHRS2Specification developeraccessdata.fda.gov
Pliers, SurgicalHTC1Specification developeraccessdata.fda.gov
Posterior Cervical Screw SystemNKG2Specification developeraccessdata.fda.gov
ProbeHXB1Specification developeraccessdata.fda.gov
RaspHTR1Specification developeraccessdata.fda.gov
Rasp, Surgical, General & Plastic SurgeryGAC1Specification developeraccessdata.fda.gov
ReamerHTO1Specification developeraccessdata.fda.gov
RetractorGAD1Specification developeraccessdata.fda.gov
Retractor, Self-Retaining, For NeurosurgeryGZT2Specification developeraccessdata.fda.gov
RongeurHTX1Specification developeraccessdata.fda.gov
Scalpel, One-PieceGDX1Specification developeraccessdata.fda.gov
Screw, Fixation, BoneHWC2Specification developeraccessdata.fda.gov
ScrewdriverHXX1Specification developeraccessdata.fda.gov
Shunt, Central Nervous System And ComponentsJXG2Specification developeraccessdata.fda.gov
Spinal Vertebral Body Replacement DeviceMQP2Specification developeraccessdata.fda.gov
Spinal Vertebral Body Replacement Device - CervicalPLR2Specification developeraccessdata.fda.gov
Stand, InfusionFOX1Specification developeraccessdata.fda.gov
Staple, Fixation, BoneJDR2Specification developeraccessdata.fda.gov
Sterilant, Medical DevicesMED2Specification developeraccessdata.fda.gov
Sterilization Wrap Containers, Trays, Cassettes & Other AccessoriesKCT2Specification developeraccessdata.fda.gov
Stimulator, NerveETN2Specification developeraccessdata.fda.gov
Surgical Table CushionLWG1Specification developeraccessdata.fda.gov
Suture, Absorbable, Synthetic, Polyglycolic AcidGAM2Specification developeraccessdata.fda.gov
Suture, Nonabsorbable, Synthetic, PolyesterGAS2Specification developeraccessdata.fda.gov
Suture, Nonabsorbable, Synthetic, PolyethyleneGAT2Specification developeraccessdata.fda.gov
Suture, Surgical, Absorbable, PolydioxanoneNEW2Specification developeraccessdata.fda.gov
Syringe, PistonFMF2Specification developeraccessdata.fda.gov
System, Facet Screw Spinal DeviceMRWUSpecification developeraccessdata.fda.gov
System, X-Ray, Tomography, ComputedJAK2Specification developeraccessdata.fda.gov
Table, Surgical With Orthopedic Accessories, ManualJEB1Specification developeraccessdata.fda.gov
TampHXG1Specification developeraccessdata.fda.gov
Tap, BoneHWX1Specification developeraccessdata.fda.gov
TemplateHWT1Specification developeraccessdata.fda.gov
Thoracolumbosacral Pedicle Screw SystemNKB2Specification developeraccessdata.fda.gov
Tissue Adhesive For Use In Embolization Of Brain Arteriovenous MalformationsKGG3Specification developeraccessdata.fda.gov
Tong, Skull For TractionHAX2Specification developeraccessdata.fda.gov
Tray, Surgical, InstrumentFSM1Specification developeraccessdata.fda.gov
TrephineHWK1Specification developeraccessdata.fda.gov
Washer, Bolt NutHTN2Specification developeraccessdata.fda.gov
Wire, Guide, CatheterDQX2Specification developeraccessdata.fda.gov
WrenchHXC1Specification developeraccessdata.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 323.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
May 26, 2026K254157CROSSNAV Navigation Enabled Instruments for Disc Preparation and InterbodyOLOSubstantially EquivalentMedos International SARLaccessdata.fda.gov
March 27, 2026K260240SYMPHONY Navigation Ready InstrumentsOLOSubstantially EquivalentMedos International SARLaccessdata.fda.gov
February 26, 2026K253791PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula System LidKCTSubstantially EquivalentDePuy Mitek, Inc.accessdata.fda.gov
October 21, 2025K253249TriALTIS™ Spine SystemNKBSubstantially EquivalentMedos International SARLaccessdata.fda.gov
February 5, 2025K243790GRYPHON™ X Anchor; HEALIX TRANSTEND™ AnchorMAISubstantially EquivalentDepuy Mitekaccessdata.fda.gov
January 17, 2025K243249TriALTIS™ Spine SystemNKBSubstantially EquivalentMedos International SARLaccessdata.fda.gov
September 16, 2024K241893CROSSNAV Navigation Enabled Instruments and UNAS Navigation ArraysOLOSubstantially EquivalentMedos International SARLaccessdata.fda.gov
September 11, 2024K241010HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self-Punching anchorsMAISubstantially EquivalentDepuy Mitekaccessdata.fda.gov
September 9, 2024K242042TriALTIS™ Spine SystemNKBSubstantially EquivalentMedos International SARLaccessdata.fda.gov
June 17, 2024K233256Robotic Integration InstrumentsOLOSubstantially EquivalentDePuy Synthesaccessdata.fda.gov
June 17, 2024K233255CROSSNAV Navigation Enabled InstrumentsOLOSubstantially EquivalentDePuy Synthesaccessdata.fda.gov
June 14, 2024K233254TELIGEN System Navigation Ready InstrumentsOLOSubstantially EquivalentDePuy Synthesaccessdata.fda.gov
June 14, 2024K233228Spine Navigation and Robotic-Assistance DeviceOLOSubstantially EquivalentEcential Roboticsaccessdata.fda.gov
March 15, 2024K240441MILAGRO Interference Screw; MILAGRO ADVANCE Interference ScrewMAISubstantially EquivalentDepuy Mitekaccessdata.fda.gov
December 12, 2023K233684TriALTIS™ Spine SystemNKBSubstantially EquivalentMedos International SARLaccessdata.fda.gov
November 9, 2023K233366SYMPHONY OCT SystemNKGSubstantially EquivalentMedos International SARLaccessdata.fda.gov
October 6, 2023K2324922.7 mm GRYPHON™ Flex Knotless PEEK Anchor; 2.7 mm GRYPHON™ Flex Knotless Biocomposite AnchorMBISubstantially EquivalentMedos International SARLaccessdata.fda.gov
September 29, 2023K231527TriALTIS Navigation Enabled InstrumentsOLOSubstantially EquivalentMedos International Sàrlaccessdata.fda.gov
September 22, 2023K231479TriALTIS Spine SystemNKBSubstantially EquivalentMedos International SARLaccessdata.fda.gov
March 8, 2023K223688CONDUIT™ Lateral Lumbar Intervertebral Fusion Cage, CONDUIT™ InstrumentsMAXSubstantially EquivalentMedos International Sàrlaccessdata.fda.gov
February 10, 2023K223438TELIGEN System Peripheral Motor Nerve Stimulation IndicationsPDQSubstantially EquivalentMedos International SARLaccessdata.fda.gov
January 19, 2023K223108TELIGEN System Navigation Ready Indications (TELIGEN Access Probe, TELIGEN Clear)OLOSubstantially EquivalentMedos International SARLaccessdata.fda.gov
October 18, 2022K213978TELIGEN SystemHRXSubstantially EquivalentMedos International SARLaccessdata.fda.gov
October 13, 2022K222473EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE™ Ultra RodsNKBSubstantially EquivalentMedos-International Sarlaccessdata.fda.gov
August 25, 2022K221325CONDUIT Lateral Switch PlateMAXSubstantially EquivalentMedos International SARLaccessdata.fda.gov
July 14, 2022K220040CEREPAK Uniform, Uniform XL, Uniform 3D, Heliform Soft, Heliform XtraSoft, Heliform XL, Heliform XtraSoft XL, Freeform, Freeform Mini, and Freeform XtraSoft Detachable Coil SystemsHCGSubstantially EquivalentMedos International SARLaccessdata.fda.gov
July 11, 2022K221364Mitek TIGHT-N AnchorMBISubstantially EquivalentMedos International SARLaccessdata.fda.gov
May 5, 2022K212756Discectomy Navigation Ready Instruments and Universal Navigation Adaptor SetOLOSubstantially EquivalentMedos International SARLaccessdata.fda.gov
April 26, 2022K220219PERMALOOP Suture, PERMATAPE SutureGATSubstantially EquivalentMedos International SARLaccessdata.fda.gov
April 12, 2022K214025PROWLER SELECT LP ES Microcatheter; PROWLER XS MicrocatheterKRASubstantially EquivalentMedos International SARLaccessdata.fda.gov
August 25, 2021K210838PROWLER SELECT PLUS; PROWLER EXKRASubstantially EquivalentMedos International SARLaccessdata.fda.gov
May 28, 2021K211344MICRUSFRAME, DELTAFILL, DELTAXSFT, GALAXY G3, GALAXY G3 XSFT, and GALAXY G3 Mini Microcoil Delivery SystemsHCGSubstantially EquivalentMedos International SARLaccessdata.fda.gov
May 6, 2021K210728CONDUIT InstrumentsMAXSubstantially EquivalentMedos International SARLaccessdata.fda.gov
March 18, 2021K203186DYNATAPE SutureGATSubstantially EquivalentMedos International SARLaccessdata.fda.gov
February 5, 2021K203319SYMPHONY™ OCT SystemNKGSubstantially EquivalentMedos International SARLaccessdata.fda.gov
February 1, 2021K203794HEALIX Ti Dual Threaded Suture Anchor with DYNATAPE SutureMBISubstantially EquivalentMedos International SARLaccessdata.fda.gov
September 16, 2020K201661Symphony Navigation Ready Instruments and Universal Navigation Adaptor SetOLOSubstantially EquivalentMedos International SARLaccessdata.fda.gov
August 7, 2020K2018836.5 mm Healix Advance SP Peek Anchor, 6.5 mm Healix Advance SP Biocomposite AnchorMBISubstantially EquivalentMedos International SARLaccessdata.fda.gov
July 31, 2020K200791Navigation Enabled IntrumentsOLOSubstantially EquivalentMedos International SARLaccessdata.fda.gov
July 20, 2020K193380CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing SetNRYSubstantially EquivalentCodman & Shurtleff, Inc.accessdata.fda.gov
June 4, 2020K200949HEALIX ADVANCE Anchor with DYNATAPE SutureMBISubstantially EquivalentMedos International SARLaccessdata.fda.gov
April 24, 2020K200245EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine SystemNKBSubstantially EquivalentMedos International Sàrlaccessdata.fda.gov
April 2, 2020K192646SYMPHONY™ OCT SystemNKGSubstantially EquivalentMedos International SARLaccessdata.fda.gov
February 27, 2020K192804CEREBASE DA Guide Sheath, 95cm, CEREBASE DA Guide Sheath, 90cm, CEREBASE DA Guide Sheath, 80cm, CEREBASE DA Guide Sheath, 70cmQJPSubstantially EquivalentMedos International SARLaccessdata.fda.gov
January 24, 2020K192014SYPMHONY™ OCT SystemNKGSubstantially EquivalentMedos International SARLaccessdata.fda.gov
December 20, 2019K190284Bengal Stackable Cage SystemPLRSubstantially EquivalentMedos International SARLaccessdata.fda.gov
November 20, 2019K192281AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation System, Anterior ISOLA Spine System, BOWTI Anterior Buttress Staple Spinal System, DISCOVERY Screw System, EXPEDIUM Anterior Spine System, FRONTIER Anterior Scoliosis System, KANEDA Anterior Scoliosis System, KANEDA SR Anterior Spinal System, M-2 Anterior Plate System, MOUNTAINEER Laminoplasty System, PROFILE Anterior Thoracolumbar Plate System, UNIVERSITY PLATE Anterior System, VIPER F2 Facet Fixation SystemMRWSubstantially EquivalentMedos International SARLaccessdata.fda.gov
November 8, 2019K191237CERENOVUS Large Bore CatheterDQYSubstantially EquivalentCodman & Shurtleff, Inc.accessdata.fda.gov
October 18, 2019K191943SYMPHONY Navigation Ready Instruments, Universal Navigation Adaptor SetOLOSubstantially EquivalentMedos International SARLaccessdata.fda.gov
September 24, 2019K191212CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated Screw System, EXPEDIUM SFX Cross Connectors, EXPEDIUM Spine System, EXPEDIUM VERSE Spine System, E-Z Link Cross Connectors, ISOLA Spine System, MONARCH Spine System, MOSS MIAMI Spine System, TiMX Low Back System, VIPER Fenestrated Screw System, VIPER PRIME System, VIPER PRIME Fenestrated Screws, VIPER SAI (Sacral-Alar-Iliac), VIPER System, VIPER 2 System, VSP Spine SystemPGMSubstantially EquivalentMedos International SARLaccessdata.fda.gov
August 22, 2019K191242HEALIX ADVANCE SP BIOCOMPOSITE AnchorMAISubstantially EquivalentMedos International SARLaccessdata.fda.gov
July 25, 2019K190774RIGIDLOOP Titanium Button , RIGIDLOOP Cortical Fixation System XL ImplantMBISubstantially EquivalentMedos International SARLaccessdata.fda.gov
July 18, 2019K190895MOUNTAINEER OCT Spinal System, SUMMIT SI OCT Spinal Fixation System, SYMPHONY OCT System, SUMMIT Fixation SystemNKGSubstantially EquivalentMedos International SARLaccessdata.fda.gov
June 28, 2019K191483HEALIX ADVANCE Anchor with DYNA+TAPE SuturesMBISubstantially EquivalentMedos International SARLaccessdata.fda.gov
February 26, 2019K182941HEALIX ADVANCE SP PEEK AnchorMBISubstantially EquivalentMedos International SARLaccessdata.fda.gov
February 21, 2019K183279HEALIX Ti ANCHOR with DYNACORDMBISubstantially EquivalentMedos International SARLaccessdata.fda.gov
November 20, 2018K182265CodMan Certas Plus Programmable ValveJXGSubstantially EquivalentIntegra Lifesciences Corp.accessdata.fda.gov
October 25, 2018K181902Codman Certas Plus Electronic Tool KitJXGSubstantially EquivalentIntegra Lifesciences Corp.accessdata.fda.gov
October 4, 2018K181949SYMPHONY™ OCT SystemNKGSubstantially EquivalentMedos International SARLaccessdata.fda.gov
August 3, 2018K181809GRYPHON® Anchors with DYNACORD™ SutureMAISubstantially EquivalentMedos International SARLaccessdata.fda.gov
August 2, 2018K181182DYNACORD SutureGATSubstantially EquivalentMedos International SARLaccessdata.fda.gov
June 11, 2018K173787X-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® SystemMQPSubstantially EquivalentMedos International SARLaccessdata.fda.gov
May 10, 2018K180101HEALIX ADVANCE KNOTLESS BR AnchorMAISubstantially EquivalentMedos International SARLaccessdata.fda.gov
April 11, 2018K173859HEALIX ADVANCE Anchor with DYNACORD SutureMAISubstantially EquivalentMedos International SARLaccessdata.fda.gov
April 5, 2018K173526SENTIO MMG Gen 2PDQSubstantially EquivalentMedos International SARLaccessdata.fda.gov
March 22, 2018K173134SENTIO MMG Pedicle Access NeedlesPDQSubstantially EquivalentMedos International SARLaccessdata.fda.gov
February 8, 2018K173537CONCORDE LIFT™MAXSubstantially EquivalentMedos International SARLaccessdata.fda.gov
January 18, 2018K171237FMS VUE II Fluid Management and Tissue Debridement SystemHRXSubstantially EquivalentMedos International SARLaccessdata.fda.gov
November 27, 2017K171114HEALIX ADVANCE KNOTLESS AnchorMAISubstantially EquivalentMedos International SARLaccessdata.fda.gov
October 25, 2017K173095VIPER PRIME™ Screws, VIPER PRIME™ Screws with Fenestrations, EXPEDIUM® Verse Screws with FenestrationsNKBSubstantially EquivalentMedos International SARLaccessdata.fda.gov
September 25, 2017K171862GALAXY G3 Mini Microcoil Delivery SystemHCGSubstantially EquivalentCodman & Shurtleff, Inc.accessdata.fda.gov
September 14, 2017K170937VIPER PRIME navigated inserterOLOSubstantially EquivalentMedos International SARLaccessdata.fda.gov
August 31, 2017K171570Additional VIPER PRIME™ screws with fenestrationsNKBSubstantially EquivalentMedos International SARLaccessdata.fda.gov
July 20, 2017K171439EAGLE 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 SystemKWQSubstantially EquivalentMedos International SARLaccessdata.fda.gov
July 20, 2017K171425CONCORDE LIFTMAXSubstantially EquivalentMedos International SARLaccessdata.fda.gov
July 14, 2017K171747MICRUSFRAME 10 Stretch Resistant Microcoil Delivery System, MICRUSFRAME 18 Stretch Resistant Microcoil Delivery System, DELTAFILL 18 Stretch Resistant Microcoil Delivery System, DELTAXSFT 10 Stretch Resistant Microcoil Delivery System, GALAXY G3 FILL and GALAXY G3 XSFT Stretch Resistant Microcoil Delivery SystemHCGSubstantially EquivalentCodman & Shurtleff, Inc.accessdata.fda.gov
July 3, 2017K171653YOGA Microcatheter, 0.032, 150cm, Back Up and Extra Back UpDQYSubstantially EquivalentCodman & Shurtleff, Inc.accessdata.fda.gov
May 18, 2017K170639HEALIX ADVANCE Anchor with PERMATAPE SutureMAISubstantially EquivalentMedos International SARLaccessdata.fda.gov
May 4, 2017K170543VIPER PRIME™ Screws with FenestrationsNKBSubstantially EquivalentMedos International SARLaccessdata.fda.gov
January 5, 2017K162563YOGA MicrocatheterDQYSubstantially EquivalentCodman & Shurtleff, Inc.accessdata.fda.gov
December 20, 2016K160879CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw SystemsPMLSubstantially EquivalentMedos International Sàrlaccessdata.fda.gov
December 15, 2016K162247PERMATAPEGATSubstantially EquivalentMedos International SARLaccessdata.fda.gov
December 12, 2016K162327COUGAR® LS Lateral Cage System and COUGAR® SystemMAXSubstantially EquivalentMedos International SARLaccessdata.fda.gov
December 8, 2016K162912VIPER PRIME™ additions to the VIPER® SystemNKBSubstantially EquivalentMedos International SARLaccessdata.fda.gov
December 1, 2016K163106CODMAN Integrated Bipolar Cord and Tubing SetGEISubstantially EquivalentMedos International SARLaccessdata.fda.gov
November 7, 2016K161638SPEEDTRAP Graft Preparation SystemGATSubstantially EquivalentMedos International SARLaccessdata.fda.gov
July 19, 2016K160804INTRAFIX(TM) Advance Tibial Fastener SystemMAISubstantially EquivalentMedos International SARLaccessdata.fda.gov
July 1, 2016K160904Expedium Spine System, VIPER and VIPER 2 SystemsNKBSubstantially EquivalentMedos International SARLaccessdata.fda.gov
June 9, 2016K161001MILAGRO ADVANCE PEEK Interference ScrewMBISubstantially EquivalentMedos International SARLaccessdata.fda.gov
April 4, 2016K160464Opticage(R) Expandable Interbody Fusion DeviceMAXSubstantially EquivalentInterventional Spine, Inc.accessdata.fda.gov
March 24, 2016K153667TRUESPAN Meniscal Repair SystemMBISubstantially EquivalentMedos International SARLaccessdata.fda.gov
January 22, 2016K152670DirectLink ICP Module, DirectLink ICP Extension Cable, Patient Monitor Interface CablesGWMSubstantially EquivalentMedos International SARLaccessdata.fda.gov
November 20, 2015K151773CONCORDE Bullet Lumbar Interbody SystemMAXSubstantially EquivalentMedos International SARLaccessdata.fda.gov
October 27, 2015K152152Codman Certas Plus Programmable ValveJXGSubstantially EquivalentMedos International SARLaccessdata.fda.gov
October 19, 2015K152156Opticage Expandable Interbody Fusion DeviceMAXSubstantially EquivalentInterventional Spine, Inc.accessdata.fda.gov
October 8, 2015K151352CONCORDE Bullet Spinal SystemMAXSubstantially EquivalentMedos International SARLaccessdata.fda.gov
October 6, 2015K150209Healix 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 AncMAISubstantially EquivalentDepuy Mitek, A Johnson and Johnson Companyaccessdata.fda.gov
September 3, 2015K151885SUMMIT SI OCT Spinal Fixation System, MOUNTAINEER OCT Spinal SystemNKGSubstantially EquivalentDepuy Synthes, Inc.accessdata.fda.gov
June 12, 2015K150319MICRUSFRAME 10/18, DELTAFILL 18, DELTAXSFT 10, GALAXY G3 FILL/XSFT STRETCH RESISTANT MICROCOIL DELIVERY SYSTEMSHCGSubstantially EquivalentCodman & Shurtleff, Inc.accessdata.fda.gov
April 3, 2015K143475VAPR Tripolar Suction ElectrodeGEISubstantially EquivalentDepuy Mitekaccessdata.fda.gov

PMA approvals

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

ApprovedPMA numberDeviceProduct codeSupplementsLatest decisionSource
September 25, 2000P990040TRUFILL N-BUTYL CYANOACRYLATE LIQUID EMBOLIC SYSTEMKGG37October 23, 2026accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

InitiatedEventClassStatusProductReasonSource
July 23, 202699467Class IIOngoingVelys Enabling Tech Robotic-Assist Station REF: 451611001Software issue within robotic controller which may cause unintended movement of the robotic arm during bone preparation or instrument positioning.accessdata.fda.gov
February 2, 202493955Class IOngoingCERENOVUS CEREBASE DA Guide Sheath, Part Numbers: a) GS9080SD; b) GS9090SD; c) GS9095SD; Vascular guide-catheter, single-useMedos has received an increase in complaints for CEREBASE DA Guide Sheath with reports of fractures at the distal end, which may result in surgical procedural delay, vascular injury and in extreme rare occasions it may result in embolism.accessdata.fda.gov

Compare with other makers

Updated October 23, 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.