# Medicrea International S.A.S. (Medtronic)

- Location (FDA's records): Rillieux-La-Pape, FR
- FDA decisions: 4 (2024–2026): 4 510(k) clearances
- Product codes: QIH (2), MAX (2)
- 510(k) review time since 2016: median 52 days, against 111 for FDA's reviews in the same codes and years (3 of 4 faster)
- Predicates its devices cite: 6 (2 its own); citations of its devices by later devices: 2 (2 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Medicrea International SA: 2 (https://510kreport.com/company/medicrea-international)
- Medtronic Sofamor Danek USA, Inc.: 1 (https://510kreport.com/company/medtronic-sofamor-danek-usa)
- Medtronic Sofamor Danek: 1 (https://510kreport.com/company/medtronic-sofamor-danek)

## Its most-cited devices
- K251629: UNiD™ Spine Analyzer (2025), cited by 1
- K241164: IB3D™ PL Spinal System (2024), cited by 1

## Recent decisions
- K261289: UNiD™ Spine Analyzer (SW3002) (May 15, 2026)
- K253577: IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter) (Dec 19, 2025)
- K251629: UNiD™ Spine Analyzer (Aug 7, 2025)
- K241164: IB3D™ PL Spinal System (Sep 6, 2024)

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