510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Medos International SARL

Le Locle Neuchatel, CH

MEDOS INTERNATIONAL SARL appears in FDA device records in Le Locle Neuchatel, CH. FDA records list 101 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
101
PMA records
0
Recall records
2
Registered establishments
1

510(k) clearance history

Showing 50 of 101

FDA records hold 101 510(k) clearances for Medos International SARL between 2010 and 2026. The busiest year on record is 2016, with 12. The most recent is 2026, with 2.

Clearances by year, as a table
510(k) clearance decisions for Medos International SARL, by decision year
YearClearances
20101
20114
20127
20133
20143
20154
201612
20178
201810
201912
20208
20216
20229
20238
20242
20252
20262
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K254157CROSSNAV Navigation Enabled Instruments for Disc Preparation and InterbodyOLOSubstantially Equivalent
K260240SYMPHONY Navigation Ready InstrumentsOLOSubstantially Equivalent
K253249TriALTIS™ Spine SystemNKBSubstantially Equivalent
K243249TriALTIS™ Spine SystemNKBSubstantially Equivalent
K241893CROSSNAV Navigation Enabled Instruments and UNAS Navigation ArraysOLOSubstantially Equivalent
K242042TriALTIS™ Spine SystemNKBSubstantially Equivalent
K233684TriALTIS™ Spine SystemNKBSubstantially Equivalent
K233366SYMPHONY OCT SystemNKGSubstantially Equivalent
K2324922.7 mm GRYPHON™ Flex Knotless PEEK Anchor; 2.7 mm GRYPHON™ Flex Knotless Biocomposite AnchorMBISubstantially Equivalent
K231527TriALTIS Navigation Enabled InstrumentsOLOSubstantially Equivalent
K231479TriALTIS Spine SystemNKBSubstantially Equivalent
K223688CONDUIT™ Lateral Lumbar Intervertebral Fusion Cage, CONDUIT™ InstrumentsMAXSubstantially Equivalent
K223438TELIGEN System Peripheral Motor Nerve Stimulation IndicationsPDQSubstantially Equivalent
K223108TELIGEN System Navigation Ready Indications (TELIGEN Access Probe, TELIGEN Clear)OLOSubstantially Equivalent
K213978TELIGEN SystemHRXSubstantially Equivalent
K222473EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE™ Ultra RodsNKBSubstantially Equivalent
K221325CONDUIT Lateral Switch PlateMAXSubstantially Equivalent
K220040CEREPAK Uniform, Uniform XL, Uniform 3D, Heliform Soft, Heliform XtraSoft, Heliform XL, Heliform XtraSoft XL, Freeform, Freeform Mini, and Freeform XtraSoft Detachable Coil SystemsHCGSubstantially Equivalent
K221364Mitek TIGHT-N AnchorMBISubstantially Equivalent
K212756Discectomy Navigation Ready Instruments and Universal Navigation Adaptor SetOLOSubstantially Equivalent
K220219PERMALOOP Suture, PERMATAPE SutureGATSubstantially Equivalent
K214025PROWLER SELECT LP ES Microcatheter; PROWLER XS MicrocatheterKRASubstantially Equivalent
K220374EXPEDIUM VERSE® Fenestrated Screw System (Sterile Fenestrated Screws)NKBSubstantially Equivalent
K210838PROWLER SELECT PLUS; PROWLER EXKRASubstantially Equivalent
K211344MICRUSFRAME, DELTAFILL, DELTAXSFT, GALAXY G3, GALAXY G3 XSFT, and GALAXY G3 Mini Microcoil Delivery SystemsHCGSubstantially Equivalent
K210728CONDUIT InstrumentsMAXSubstantially Equivalent
K203186DYNATAPE SutureGATSubstantially Equivalent
K203319SYMPHONY™ OCT SystemNKGSubstantially Equivalent
K203794HEALIX Ti Dual Threaded Suture Anchor with DYNATAPE SutureMBISubstantially Equivalent
K201661Symphony Navigation Ready Instruments and Universal Navigation Adaptor SetOLOSubstantially Equivalent
K2018836.5 mm Healix Advance SP Peek Anchor, 6.5 mm Healix Advance SP Biocomposite AnchorMBISubstantially Equivalent
K200791Navigation Enabled IntrumentsOLOSubstantially Equivalent
K200949HEALIX ADVANCE Anchor with DYNATAPE SutureMBISubstantially Equivalent
K200245EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine SystemNKBSubstantially Equivalent
K192646SYMPHONY™ OCT SystemNKGSubstantially Equivalent
K192804CEREBASE DA Guide Sheath, 95cm, CEREBASE DA Guide Sheath, 90cm, CEREBASE DA Guide Sheath, 80cm, CEREBASE DA Guide Sheath, 70cmQJPSubstantially Equivalent
K192014SYPMHONY™ OCT SystemNKGSubstantially Equivalent
K190284Bengal Stackable Cage SystemPLRSubstantially Equivalent
K192281AEGIS 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 Equivalent
K191943SYMPHONY Navigation Ready Instruments, Universal Navigation Adaptor SetOLOSubstantially Equivalent
K191212CrossOver 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 Equivalent
K191242HEALIX ADVANCE SP BIOCOMPOSITE AnchorMAISubstantially Equivalent
K190774RIGIDLOOP Titanium Button , RIGIDLOOP Cortical Fixation System XL ImplantMBISubstantially Equivalent
K190895MOUNTAINEER OCT Spinal System, SUMMIT SI OCT Spinal Fixation System, SYMPHONY OCT System, SUMMIT Fixation SystemNKGSubstantially Equivalent
K191483HEALIX ADVANCE Anchor with DYNA+TAPE SuturesMBISubstantially Equivalent
K182349CONCORDE LIFTMAXSubstantially Equivalent
K182941HEALIX ADVANCE SP PEEK AnchorMBISubstantially Equivalent
K183279HEALIX Ti ANCHOR with DYNACORDMBISubstantially Equivalent
K183506HEALIX ADVANCE Anchor with DYNACORD SutureMAISubstantially Equivalent
K181949SYMPHONY™ OCT SystemNKGSubstantially Equivalent

Registered establishments

FDA registered establishments for Medos International SARL, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30081149653008114965MEDOS INTERNATIONAL SARLChemin-Blanc 38, Le Locle Neuchatel 2400 CH2026and 129 more, listed in full below

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-3088-2026Velys 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.Class IIOpen, Classified
Z-1284-2024CERENOVUS 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.Class IOpen, Classified

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Data as of , FDA export datePage updated Source: openFDA, public domain