# BAAT Medical Products B.V.

- Location (FDA's records): Hengelo, NL
- FDA decisions: 6 (2020–2026): 6 510(k) clearances
- Product codes: MBI (2), HSB (1), PGM (1), MAX (1), JDO (1)
- 510(k) review time since 2016: median 104 days, against 86 for FDA's reviews in the same codes and years (1 of 4 faster)
- Predicates its devices cite: 8 (1 its own); citations of its devices by later devices: 1 (1 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 Synthes: 1 (https://510kreport.com/company/depuy-synthes)
- Intrafuse, LLC: 1 (https://510kreport.com/company/intrafuse)
- Conextions Medical: 1 (https://510kreport.com/company/conextions-medical)
- Medtronic Sofamor Danek USA, Inc.: 1 (https://510kreport.com/company/medtronic-sofamor-danek-usa)
- Osseus Fusion Systems, LLC: 1 (https://510kreport.com/company/osseus-fusion-systems)
- K2m, Inc.: 1 (https://510kreport.com/company/k2m)
- Nu Vasive, Incorporated: 1 (https://510kreport.com/company/nu-vasive)

## Its most-cited devices
- K220966: Sinefix (2023), cited by 1

## Recent decisions
- K262184: Gannet® (Oct 22, 2026)
- K254176: Sinefix (Mar 16, 2026)
- K251961: SDS Growing Rod (Jan 15, 2026)
- K220966: Sinefix (Mar 8, 2023)
- K211474: Kleiner KG2 System (Sep 14, 2021)
- K201830: ANSER Clavicle Pin (Aug 27, 2020)

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