# ZheJiang Decans Medical Devices Co., Ltd.

- Location (FDA's records): Jiaxing, CN
- FDA decisions: 11 (2024–2026): 11 510(k) clearances
- Product codes: OVE (2), MBI (2), ODP (1), MAX (1), HSB (1), KWQ (1), NKG (1), NKB (1), NQW (1)
- 510(k) review time since 2016: median 235 days, against 76 for FDA's reviews in the same codes and years (1 of 10 faster)
- Predicates its devices cite: 36 (2 its own); citations of its devices by later devices: 2 (2 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
- Synthes Spine: 5 (https://510kreport.com/company/synthes-spine)
- Medtronic Sofamor Danek: 4 (https://510kreport.com/company/medtronic-sofamor-danek)
- Medtronic Sofamor Danek USA, Inc.: 4 (https://510kreport.com/company/medtronic-sofamor-danek-usa)
- Arthrex, Inc.: 4 (https://510kreport.com/company/arthrex)
- Smith & Nephew, Inc.: 4 (https://510kreport.com/company/smith-nephew)
- Depuy Spine, Inc.: 2 (https://510kreport.com/company/depuy-spine)
- Double Medical Technology, Inc.: 2 (https://510kreport.com/company/double-medical-technology)
- Stryker Spine: 2 (https://510kreport.com/company/stryker-spine)

## Its most-cited devices
- K242195: Gemini Cervical Fusion Cage System (2024), cited by 1
- K242267: Gemini Medical Cage System (2024), cited by 1

## Recent decisions
- K253046: HERA Interlocking Intramedullary Nailing System (Jun 16, 2026)
- K253195: TAURUS Posterior Occipital-Cervico-Thoracic Spinal Systems (Jun 2, 2026)
- K252930: AQUA Laminoplasty Systems (May 27, 2026)
- K253130: Dione PEEK Screw System (May 27, 2026)
- K252776: ARIES Anterior Cervical Plate Systems (May 14, 2026)
- K252542: LEO Spinal System (Apr 29, 2026)
- K253213: SAGI Cervical Cage System (Apr 20, 2026)
- K252774: Uni-C Cervical Cage System (Apr 15, 2026)

Source page: https://510kreport.com/company/zhejiang-decans-medical-devices