# Orthorebirth Co., Ltd.

- Location (FDA's records): Yokohama, JP
- FDA decisions: 4 (2014–2024): 4 510(k) clearances
- Product codes: MQV (4)
- 510(k) review time since 2016: median 109 days, against 124 for FDA's reviews in the same codes and years (3 of 3 faster)
- Predicates its devices cite: 5 (1 its own); citations of its devices by later devices: 1 (1 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
- Apatech, Ltd.: 2 (https://510kreport.com/company/apatech)
- Medtronic Sofamor Danek USA, Inc.: 1 (https://510kreport.com/company/medtronic-sofamor-danek-usa)
- Ossdsign AB: 1 (https://510kreport.com/company/ossdsign)

## Its most-cited devices
- K172573: ReBOSSIS85 (2017), cited by 1

## Recent decisions
- K240453: ReBOSSIS (Mar 4, 2024)
- K172573: ReBOSSIS85 (Dec 15, 2017)
- K170620: ReBOSSIS85 (Jun 23, 2017)
- K142090: Rebossis (Oct 29, 2014)

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