# Medicrea International SA

- Location (FDA's records): Neyron, FR
- FDA decisions: 44 (2011–2026): 44 510(k) clearances
- Names in FDA's records: Medicrea International SA (25); Medicrea International (17); Medicrea International, Inc. (1); Medicrea International S.A.S (1)
- Product codes: NKB (9), OWI (6), MAX (6), NKG (5), LLZ (3), OSH (3), MNI (3), KWQ (2), MNH (2), OVD (1), KWP (1), PHQ (1)
- 510(k) review time since 2016: median 120 days, against 96 for FDA's reviews in the same codes and years (11 of 26 faster)
- Predicates its devices cite: 119 (41 its own); citations of its devices by later devices: 69 (41 its own)
- Recalls linked to its devices: 11 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Medicrea Technologies: 17 (https://510kreport.com/company/medicrea-technologies)
- Medtronic Sofamor Danek USA, Inc.: 12 (https://510kreport.com/company/medtronic-sofamor-danek-usa)
- Medtronic Sofamor Danek: 5 (https://510kreport.com/company/medtronic-sofamor-danek)
- Depuy Spine, Inc.: 4 (https://510kreport.com/company/depuy-spine)
- Zimmer Spine, Inc.: 4 (https://510kreport.com/company/zimmer-spine)
- Medtronic, Inc.: 4 (https://510kreport.com/company/medtronic)
- Medicrea: 3 (https://510kreport.com/company/medicrea)
- Depuy, Inc.: 3 (https://510kreport.com/company/depuy)

## Firms that cite its devices most
- S.M.A.I.O: 4 (https://510kreport.com/company/smaio)
- Globus Medical, Inc.: 4 (https://510kreport.com/company/globus-medical)
- Alphatec Spine, Inc.: 4 (https://510kreport.com/company/alphatec-spine)
- K2m, Inc.: 3 (https://510kreport.com/company/k2m)
- Medtronic, Inc.: 3 (https://510kreport.com/company/medtronic)
- Carlsmed, Inc.: 3 (https://510kreport.com/company/carlsmed)
- Medicrea International S.A.S. (Medtronic): 2 (https://510kreport.com/company/medicrea-international-medtronic)
- Astura Medical: 2 (https://510kreport.com/company/astura-medical)

## Its most-cited devices
- K140738: Pass LP Spinal System (2014), cited by 9
- K123138: Pass LP Spinal System (2013), cited by 6
- K163595: IMPIX 3D Print Cages (2017), cited by 5
- K150918: PASS OCT Spinal System (2015), cited by 4
- K141398: Pass LP Spinal System (2015), cited by 4
- K112736: Pass LP Spinal (2012), cited by 4

## Recent decisions
- K261374: LigaPASS™ System (May 27, 2026)
- K213659: LigaPASS™ 2.0 Ligament Augmentation System (May 24, 2022)
- K220810: Infinity™ OCT System and PASS OCT Spinal System (Apr 19, 2022)
- K220724: CD Horizon™ Spinal System and PASS LP™ Spinal System (Apr 8, 2022)
- K212005: UNiD Spine Analyzer (Jan 12, 2022)
- K213281: PASS LP™ Spinal System, CD Horizon™ Spinal System (Jan 5, 2022)
- K210470: C-CURVE Interbody Fusion Device (Sep 3, 2021)
- K200316: UNiD IB3D ALIF (Oct 30, 2020)

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