# Neo Medical SA

- Location (FDA's records): Villette (Lavaux), CH
- FDA decisions: 6 (2017–2024): 6 510(k) clearances
- Product codes: PML (2), NKB (2), MAX (2)
- 510(k) review time since 2016: median 134 days, against 100 for FDA's reviews in the same codes and years (1 of 4 faster)
- Predicates its devices cite: 24 (3 its own); citations of its devices by later devices: 5 (3 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
- Medtronic Sofamor Danek USA, Inc.: 5 (https://510kreport.com/company/medtronic-sofamor-danek-usa)
- Depuy Spine, Inc.: 2 (https://510kreport.com/company/depuy-spine)
- Depuy Spine, A Johnson & Johnson Company: 2 (https://510kreport.com/company/depuy-spine-a-johnson-johnson)
- Stryker Corp.: 2 (https://510kreport.com/company/stryker)
- Spineart: 2 (https://510kreport.com/company/spineart)
- Medtronic Sofamor Danek: 2 (https://510kreport.com/company/medtronic-sofamor-danek)
- Spinevision S.A.: 2 (https://510kreport.com/company/spinevision)
- Osartis GmbH: 1 (https://510kreport.com/company/osartis)

## Firms that cite its devices most
- Spineart: 1 (https://510kreport.com/company/spineart)
- Ulrich Medical USA: 1 (https://510kreport.com/company/ulrich-medical-usa)

## Its most-cited devices
- K212489: BonOs Inject Bone Cement; NEO Pedicle Screw System (2021), cited by 2
- K222256: BonOs® Inject Bone Cement; NEO Pedicle Screw System™ (2022), cited by 2
- K181048: Neo Cage System TM (2019), cited by 1

## Recent decisions
- K243693: NEO Pedicle Screw System™ (Dec 23, 2024)
- K222256: BonOs® Inject Bone Cement; NEO Pedicle Screw System™ (Aug 26, 2022)
- K212489: BonOs Inject Bone Cement; NEO Pedicle Screw System (Oct 28, 2021)
- K191796: Neo Cage System (Dec 13, 2019)
- K181048: Neo Cage System TM (Jan 29, 2019)
- K171582: NEO Pedicle Screw System™ (Sep 12, 2017)

Source page: https://510kreport.com/company/neo-medical