# Medtech S.A

- Location (FDA's records): Montpellier, FR
- FDA decisions: 8 (2009–2020): 8 510(k) clearances
- Product codes: HAW (5), OLO (3)
- 510(k) review time since 2016: median 160 days, against 104 for FDA's reviews in the same codes and years (1 of 6 faster)
- Predicates its devices cite: 11 (5 its own); citations of its devices by later devices: 17 (5 its own)
- Recalls linked to its devices: 21 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Medtech S.A.S: 2 (https://510kreport.com/company/medtech)
- Integrated Surgical Systems, Inc.: 1 (https://510kreport.com/company/integrated-surgical-systems)
- Medtronic Surgical Navigation: 1 (https://510kreport.com/company/medtronic-surgical-navigation)
- Zimmer, Inc.: 1 (https://510kreport.com/company/zimmer)
- Medtronic Navigation, Inc.: 1 (https://510kreport.com/company/medtronic-navigation)

## Firms that cite its devices most
- Medtech S.A.S: 2 (https://510kreport.com/company/medtech)
- Globus Medical, Inc.: 2 (https://510kreport.com/company/globus-medical)
- Sinovation (Beijing) Medical Technology Co., Ltd.: 1 (https://510kreport.com/company/sinovation-beijing-medical-technology)
- Zimmer Biomet Spine, Inc.: 1 (https://510kreport.com/company/zimmer-biomet-spine)
- Medtronic Navigation, Inc.: 1 (https://510kreport.com/company/medtronic-navigation)
- Mazor Robotics, Ltd.: 1 (https://510kreport.com/company/mazor-robotics)
- Koh Young Technology, Inc.: 1 (https://510kreport.com/company/koh-young-technology)
- Brain Navi Biotechnology Co., Ltd.: 1 (https://510kreport.com/company/brain-navi-biotechnology)

## Its most-cited devices
- K151511: ROSA Spine (2016), cited by 4
- K200511: ROSA ONE Brain application (2020), cited by 3
- K182417: ROSA ONE Brain Application (2019), cited by 3
- K182848: ROSA ONE Spine application (2019), cited by 3
- K151359: ROSA Brain (2015), cited by 2
- K092239: Rosa Surgical Device, Model Rosa 1.1 (2009), cited by 1

## Recent decisions
- K200511: ROSA ONE Brain application (May 29, 2020)
- K192173: ROSA ONE Spine application (Oct 29, 2019)
- K182848: ROSA ONE Spine application (Mar 22, 2019)
- K182417: ROSA ONE Brain Application (Feb 7, 2019)
- K172444: ROSA BRAIN (v3.0.0.5) (Mar 28, 2018)
- K151511: ROSA Spine (Jan 4, 2016)
- K151359: ROSA Brain (Dec 18, 2015)
- K092239: Rosa Surgical Device, Model Rosa 1.1 (Nov 17, 2009)

Source page: https://510kreport.com/company/medtech-s-a