Company · CH
Medos International SARL
FDA 510(k) clearances and medical device recalls filed under this name, 2010 to 2026. Name variants (Inc, Corp, punctuation) are merged.
97510(k) clearances (2 in 12 months)
2recalls (1 in 12 months)
2recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| NKB | Thoracolumbosacral Pedicle Screw System | 15 |
| OLO | Orthopedic Stereotaxic Instrument | 12 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 11 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 11 |
| MAI | Fastener, Fixation, Biodegradable, Soft Tissue | 8 |
| NKG | Posterior Cervical Screw System | 6 |
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | 5 |
| JXG | Shunt, Central Nervous System And Components | 4 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 4 |
| HRX | Arthroscope | 3 |
| PDQ | Neurosurgical Nerve Locator | 3 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 |
| HCG | Device, Neurovascular Embolization | 2 |
| KRA | Catheter, Continuous Flush | 2 |
| QJP | Catheter, Percutaneous, Neurovasculature | 2 |
| GWM | Device, Monitoring, Intracranial Pressure | 1 |
| KWP | Appliance, Fixation, Spinal Interlaminal | 1 |
| LXT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite | 1 |
| MQP | Spinal Vertebral Body Replacement Device | 1 |
| MRW | System, Facet Screw Spinal Device | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 26, 2026 | K254157 | CROSSNAV Navigation Enabled Instruments for Disc Preparation and Interbody Medos International SARL, CH | OLO |
| Mar 27, 2026 | K260240 | SYMPHONY Navigation Ready Instruments Medos International SARL, CH | OLO |
| Oct 21, 2025 | K253249 | TriALTIS Spine System Medos International SARL, CH | NKB |
| Jan 17, 2025 | K243249 | TriALTIS Spine System Medos International SARL, CH | NKB |
| Sep 16, 2024 | K241893 | CROSSNAV Navigation Enabled Instruments and UNAS Navigation Arrays Medos International SARL, CH | OLO |
| Sep 9, 2024 | K242042 | TriALTIS Spine System Medos International SARL, CH | NKB |
| Dec 12, 2023 | K233684 | TriALTIS Spine System Medos International SARL, CH | NKB |
| Nov 9, 2023 | K233366 | SYMPHONY OCT System Medos International SARL, CH | NKG |
| Oct 6, 2023 | K232492 | 2.7 mm GRYPHON Flex Knotless PEEK Anchor; 2.7 mm GRYPHON Flex Knotless Biocomposite Anchor Medos International SARL, CH | MBI |
| Sep 22, 2023 | K231479 | TriALTIS Spine System Medos International SARL, CH | NKB |
| Feb 10, 2023 | K223438 | TELIGEN System Peripheral Motor Nerve Stimulation Indications Medos International SARL, CH | PDQ |
| Jan 19, 2023 | K223108 | TELIGEN System Navigation Ready Indications (TELIGEN Access Probe, TELIGEN Clear) Medos International SARL, CH | OLO |
| Oct 18, 2022 | K213978 | TELIGEN System Medos International SARL, CH | HRX |
| Oct 13, 2022 | K222473 | EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE Ultra Rods Medos-International Sarl, CH | NKB |
| Aug 25, 2022 | K221325 | CONDUIT Lateral Switch Plate Medos International SARL, CH | MAX |
| Jul 14, 2022 | K220040 | CEREPAK Uniform, Uniform XL, Uniform 3D, Heliform Soft, Heliform XtraSoft, Heliform XL, Heliform XtraSoft XL, Freeform, Medos International SARL, CH | HCG |
| Jul 11, 2022 | K221364 | Mitek TIGHT-N Anchor Medos International SARL, CH | MBI |
| May 5, 2022 | K212756 | Discectomy Navigation Ready Instruments and Universal Navigation Adaptor Set Medos International SARL, CH | OLO |
| Apr 26, 2022 | K220219 | PERMALOOP Suture, PERMATAPE Suture Medos International SARL, CH | GAT |
| Apr 12, 2022 | K214025 | PROWLER SELECT LP ES Microcatheter; PROWLER XS Microcatheter Medos International SARL, CH | KRA |
| Mar 8, 2022 | K220374 | EXPEDIUM VERSE® Fenestrated Screw System (Sterile Fenestrated Screws) Medos International SARL, CH | NKB |
| Aug 25, 2021 | K210838 | PROWLER SELECT PLUS; PROWLER EX Medos International SARL, CH | KRA |
| May 28, 2021 | K211344 | MICRUSFRAME, DELTAFILL, DELTAXSFT, GALAXY G3, GALAXY G3 XSFT, and GALAXY G3 Mini Microcoil Delivery Systems Medos International SARL, CH | HCG |
| May 6, 2021 | K210728 | CONDUIT Instruments Medos International SARL, CH | MAX |
| Mar 18, 2021 | K203186 | DYNATAPE Suture Medos International SARL, CH | GAT |
| Feb 5, 2021 | K203319 | SYMPHONY OCT System Medos International SARL, CH | NKG |
| Feb 1, 2021 | K203794 | HEALIX Ti Dual Threaded Suture Anchor with DYNATAPE Suture Medos International SARL, CH | MBI |
| Sep 16, 2020 | K201661 | Symphony Navigation Ready Instruments and Universal Navigation Adaptor Set Medos International SARL, CH | OLO |
| Aug 7, 2020 | K201883 | 6.5 mm Healix Advance SP Peek Anchor, 6.5 mm Healix Advance SP Biocomposite Anchor Medos International SARL, CH | MBI |
| Jul 31, 2020 | K200791 | Navigation Enabled Intruments Medos International SARL, CH | OLO |
| Jun 4, 2020 | K200949 | HEALIX ADVANCE Anchor with DYNATAPE Suture Medos International SARL, CH | MBI |
| Apr 2, 2020 | K192646 | SYMPHONY OCT System Medos International SARL, CH | NKG |
| Feb 27, 2020 | K192804 | CEREBASE DA Guide Sheath, 95cm, CEREBASE DA Guide Sheath, 90cm, CEREBASE DA Guide Sheath, 80cm, CEREBASE DA Guide Sheath Medos International SARL, CH | QJP |
| Jan 24, 2020 | K192014 | SYPMHONY OCT System Medos International SARL, CH | NKG |
| Dec 20, 2019 | K190284 | Bengal Stackable Cage System Medos International SARL, CH | PLR |
| Nov 20, 2019 | K192281 | AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation System, Anterior ISOLA Spine System, BOWTI Anterior Buttress Medos International SARL, CH | MRW |
| Oct 18, 2019 | K191943 | SYMPHONY Navigation Ready Instruments, Universal Navigation Adaptor Set Medos International SARL, CH | OLO |
| Sep 24, 2019 | K191212 | CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated Screw System, EXPEDIUM SFX Cros Medos International SARL, CH | PGM |
| Aug 22, 2019 | K191242 | HEALIX ADVANCE SP BIOCOMPOSITE Anchor Medos International SARL, CH | MAI |
| Jul 25, 2019 | K190774 | RIGIDLOOP Titanium Button , RIGIDLOOP Cortical Fixation System XL Implant Medos International SARL, CH | MBI |
| Jul 18, 2019 | K190895 | MOUNTAINEER OCT Spinal System, SUMMIT SI OCT Spinal Fixation System, SYMPHONY OCT System, SUMMIT Fixation System Medos International SARL, CH | NKG |
| Jun 28, 2019 | K191483 | HEALIX ADVANCE Anchor with DYNA+TAPE Sutures Medos International SARL, CH | MBI |
| Apr 3, 2019 | K182349 | CONCORDE LIFT Medos International SARL, CH | MAX |
| Feb 26, 2019 | K182941 | HEALIX ADVANCE SP PEEK Anchor Medos International SARL, CH | MBI |
| Feb 21, 2019 | K183279 | HEALIX Ti ANCHOR with DYNACORD Medos International SARL, CH | MBI |
| Feb 14, 2019 | K183506 | HEALIX ADVANCE Anchor with DYNACORD Suture Medos International SARL, CH | MAI |
| Oct 4, 2018 | K181949 | SYMPHONY OCT System Medos International SARL, CH | NKG |
| Aug 3, 2018 | K181809 | GRYPHON® Anchors with DYNACORD Suture Medos International SARL, CH | MAI |
| Aug 2, 2018 | K181182 | DYNACORD Suture Medos International SARL, CH | GAT |
| Jun 11, 2018 | K173787 | X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System, Surgical Titanium Mesh System, BEN Medos International SARL, CH | MQP |
Newest 50 of 97.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 2, 2026 | Medos International Sarl Velys Enabling Tech Robotic-Assist Station
REF: 451611001 Open, Classified |
OLO | K233228 |
| Mar 13, 2024 | Medos International Sarl CERENOVUS CEREBASE DA Guide Sheath, Part Numbers:
a) GS9080SD;
b) GS9090SD;
c) GS9095SD;
Vascular guide-catheter, single-use Open, Classified |
QJP | K192804 |