# Spinevision S.A.

- Location (FDA's records): Antony, FR
- FDA decisions: 10 (2012–2022): 10 510(k) clearances
- Names in FDA's records: Spinevision S.A. (5); Spinevision, S.A.S. (5)
- Product codes: MAX (4), OVE (2), MNI (2), NKB (1), MNH (1)
- 510(k) review time since 2016: median 75 days, against 124 for FDA's reviews in the same codes and years (4 of 7 faster)
- Predicates its devices cite: 51 (11 its own); citations of its devices by later devices: 18 (11 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Depuy Spine, Inc.: 15 (https://510kreport.com/company/depuy-spine)
- Stryker Spine: 12 (https://510kreport.com/company/stryker-spine)
- Spine Vision, Inc.: 2 (https://510kreport.com/company/spine-vision)
- Johnson & Johnson: 2 (https://510kreport.com/company/johnson-johnson)
- Nexxt Spine, LLC: 2 (https://510kreport.com/company/nexxt-spine)
- Globus Medical, Inc.: 1 (https://510kreport.com/company/globus-medical)
- Us Spine: 1 (https://510kreport.com/company/us-spine)
- Zimmer Spine, Inc.: 1 (https://510kreport.com/company/zimmer-spine)

## Firms that cite its devices most
- Neo Medical SA: 2 (https://510kreport.com/company/neo-medical)
- Kuros Biosciences B.V: 1 (https://510kreport.com/company/kuros-biosciences-b-v)
- Additive Implants, Inc.: 1 (https://510kreport.com/company/additive-implants)
- Carlsmed, Inc.: 1 (https://510kreport.com/company/carlsmed)
- Gbs Commonwealth Co., Ltd.: 1 (https://510kreport.com/company/gbs-commonwealth)
- Corentec Co., Ltd.: 1 (https://510kreport.com/company/corentec)

## Its most-cited devices
- K153783: SpaceVision® PLIF, SpaceVision® OLIF, SpaceVision® TLIF (2016), cited by 6
- K112607: Spinevision Lumis (TM) Cannulated Polyaxial Pedicle Screw Fixation System, Spinevision U.L.I.S.(TM) Polyaxial Pedicle ... (2012), cited by 3
- K193000: Hexanium® ACIF (2020), cited by 2
- K130302: Spinevision Lumis Cannulated Polyaxial Pedicle Screw Fixation System, Spinevision U.L.I.S. Polyaxial Pedicle Screw Fixat (2013), cited by 2
- K221578: Hexanium ACIF (2022), cited by 1
- K160124: LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation System (2016), cited by 1

## Recent decisions
- K223251: Hexanium PLIF (Dec 16, 2022)
- K221578: Hexanium ACIF (Nov 14, 2022)
- K210359: Hexanium TLIF (Mar 10, 2021)
- K193000: Hexanium® ACIF (Oct 20, 2020)
- K180437: Hexanium® TLIF (May 4, 2018)
- K153783: SpaceVision® PLIF, SpaceVision® OLIF, SpaceVision® TLIF (May 4, 2016)
- K160124: LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation System (Apr 4, 2016)
- K133575: Spinevision Lumis Cannulated Pedicle Screw Fixation System, Spinevision U.L.I.S. Pedicle Screw Fixation System (Jun 30, 2014)

Source page: https://510kreport.com/company/spinevision