# Shanghai Sanyou Medical Co, Ltd.

- Location (FDA's records): Jiading District, CN
- FDA decisions: 9 (2013–2023): 9 510(k) clearances
- Product codes: NKB (4), KWQ (2), MAX (2), ODP (1)
- 510(k) review time since 2016: median 164 days, against 78 for FDA's reviews in the same codes and years (2 of 8 faster)
- Predicates its devices cite: 31 (8 its own); citations of its devices by later devices: 14 (8 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: 8 (https://510kreport.com/company/medtronic-sofamor-danek)
- Medtronic Sofamor Danek USA, Inc.: 7 (https://510kreport.com/company/medtronic-sofamor-danek-usa)
- Synthes (Usa): 2 (https://510kreport.com/company/synthes-usa)
- Synthes Spine: 1 (https://510kreport.com/company/synthes-spine)
- Eit Emerging Implant Technologies GmbH: 1 (https://510kreport.com/company/eit-emerging-implant-technologies)
- Globus Medical, Inc.: 1 (https://510kreport.com/company/globus-medical)
- Captiva Spine, Inc.: 1 (https://510kreport.com/company/captiva-spine)
- Depuy Spine, A Johnson & Johnson Company: 1 (https://510kreport.com/company/depuy-spine-a-johnson-johnson)

## Firms that cite its devices most
- Implanet, S.A.: 6 (https://510kreport.com/company/implanet)

## Its most-cited devices
- K152781: Adena-Zina System (2016), cited by 4
- K163422: Shanghai Sanyou PEEK Cage System (2017), cited by 3
- K230961: Zeus Spinal System (2023), cited by 2
- K211689: KEYSTONE PEEK Cage System (2021), cited by 2
- K230872: Halis™ Lumbar Cage System, Lydia™ Anterior Lumbar Fusion System, Dica™ Direction Changeable Lumbar Cage System, KEYSTONE Cage System (2023), cited by 1
- K212066: Adena-Zina System (2021), cited by 1

## Recent decisions
- K230872: Halis™ Lumbar Cage System, Lydia™ Anterior Lumbar Fusion System, Dica™ Direction Changeable Lumbar Cage System, KEYSTONE Cage System (Dec 12, 2023)
- K230961: Zeus Spinal System (Oct 10, 2023)
- K231931: Adena-Zina Spinal System (Jul 28, 2023)
- K211689: KEYSTONE PEEK Cage System (Sep 21, 2021)
- K212066: Adena-Zina System (Aug 16, 2021)
- K163366: Shanghai Sanyou CARMEN Cervical Fusion System (Oct 5, 2017)
- K163422: Shanghai Sanyou PEEK Cage System (Sep 18, 2017)
- K152781: Adena-Zina System (Feb 12, 2016)

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