# Shanghai Reach Medical Instrument Co, Ltd.

- Location (FDA's records): Shanghai, CN
- FDA decisions: 3 (2021–2023): 3 510(k) clearances
- Product codes: NKB (2), MAX (1)
- 510(k) review time since 2016: median 140 days, against 87 for FDA's reviews in the same codes and years (1 of 3 faster)
- Predicates its devices cite: 3 (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
- Medtronic Sofamor Danek USA, Inc.: 1 (https://510kreport.com/company/medtronic-sofamor-danek-usa)
- Globus Medical, Inc.: 1 (https://510kreport.com/company/globus-medical)

## Its most-cited devices
- K201737: Posterior Spinal Fixation System (2021), cited by 1

## Recent decisions
- K232069: Expandable Lumbar Fusion Cage (Type I,Type II) (Nov 29, 2023)
- K221745: Sterile Posterior Spinal Fixation System (Aug 31, 2022)
- K201737: Posterior Spinal Fixation System (Jun 21, 2021)

Source page: https://510kreport.com/company/shanghai-reach-medical-instrument