# Medos International SARL

- Location (FDA's records): Le Locle, CH
- FDA decisions: 101 (2010–2026): 101 510(k) clearances
- Names in FDA's records: Medos International SARL (96); Medos International Sàrl (4); Medos-International Sarl (1)
- Product codes: NKB (16), MAX (12), OLO (12), MBI (11), MAI (8), NKG (6), GAT (5), JXG (4), KWQ (4), PDQ (3), HRX (3), GEI (2)
- 510(k) review time since 2016: median 91 days, against 90 for FDA's reviews in the same codes and years (34 of 76 faster)
- Predicates its devices cite: 392 (86 its own); citations of its devices by later devices: 158 (86 its own)
- Recalls linked to its devices: 25 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Depuy Spine, Inc.: 65 (https://510kreport.com/company/depuy-spine)
- Depuyacromed: 34 (https://510kreport.com/company/depuyacromed)
- Acromed Corp.: 28 (https://510kreport.com/company/acromed)
- Arthrex, Inc.: 27 (https://510kreport.com/company/arthrex)
- Depuy Mitek, A Johnson & Johnson Company: 16 (https://510kreport.com/company/depuy-mitek-a-johnson-johnson)
- Depuy, Inc.: 14 (https://510kreport.com/company/depuy)
- Johnson & Johnson: 10 (https://510kreport.com/company/johnson-johnson)
- Codman & Shurtleff, Inc.: 9 (https://510kreport.com/company/codman-shurtleff)

## Firms that cite its devices most
- CarboFix Orthopedics, Ltd.: 7 (https://510kreport.com/company/carbofix-orthopedics)
- Depuy Mitek: 6 (https://510kreport.com/company/depuy-mitek)
- DePuy Synthes: 5 (https://510kreport.com/company/depuy-synthes)
- Alphatec Spine, Inc.: 4 (https://510kreport.com/company/alphatec-spine)
- Biomet, Inc.: 4 (https://510kreport.com/company/biomet)
- S.M.A.I.O: 4 (https://510kreport.com/company/smaio)
- Spinecraft, LLC: 2 (https://510kreport.com/company/spinecraft)
- Globus Medical, Inc.: 2 (https://510kreport.com/company/globus-medical)

## Its most-cited devices
- K160879: CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw Systems (2016), cited by 11
- K151773: CONCORDE Bullet Lumbar Interbody System (2015), cited by 7
- K140759: Bengal System, Bengal Stackable System, Concorde Bullet Lumbar, Concorde Inline Lumbar, Cougar System, Cougar LS Lateral (2014), cited by 6
- K101070: Expedium Spine System (2010), cited by 5
- K160904: Expedium Spine System, VIPER and VIPER 2 Systems (2016), cited by 5
- K190895: MOUNTAINEER OCT Spinal System, SUMMIT SI OCT Spinal Fixation System, SYMPHONY OCT System, SUMMIT Fixation System (2019), cited by 5

## Recent decisions
- K254157: CROSSNAV Navigation Enabled Instruments for Disc Preparation and Interbody (May 26, 2026)
- K260240: SYMPHONY Navigation Ready Instruments (Mar 27, 2026)
- K253249: TriALTIS™ Spine System (Oct 21, 2025)
- K243249: TriALTIS™ Spine System (Jan 17, 2025)
- K241893: CROSSNAV Navigation Enabled Instruments and UNAS Navigation Arrays (Sep 16, 2024)
- K242042: TriALTIS™ Spine System (Sep 9, 2024)
- K233684: TriALTIS™ Spine System (Dec 12, 2023)
- K233366: SYMPHONY OCT System (Nov 9, 2023)

Source page: https://510kreport.com/company/medos-international