# Double Medical Technology, Inc.

- Location (FDA's records): Xiamen, CN
- FDA decisions: 12 (2016–2025): 12 510(k) clearances
- Product codes: HWC (3), HRS (2), HSB (2), KWQ (1), MNI (1), MAX (1), NKG (1), NKB (1)
- 510(k) review time since 2016: median 248 days, against 117 for FDA's reviews in the same codes and years (0 of 12 faster)
- Predicates its devices cite: 40 (3 its own); citations of its devices by later devices: 7 (3 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
- Wrightmedicaltechnologyinc: 5 (https://510kreport.com/company/wrightmedicaltechnologyinc)
- Xiamen Double Engine Medical Material Co., Ltd.: 5 (https://510kreport.com/company/xiamen-double-engine-medical-material)
- Synthes (Usa): 3 (https://510kreport.com/company/synthes-usa)
- Novastep: 3 (https://510kreport.com/company/novastep)
- Medtronic Sofamor Danek USA, Inc.: 2 (https://510kreport.com/company/medtronic-sofamor-danek-usa)
- Acumed, LLC: 2 (https://510kreport.com/company/acumed)
- Smith & Nephew, Inc.: 2 (https://510kreport.com/company/smith-nephew)
- Synthes (USA) Products, LLC: 2 (https://510kreport.com/company/synthes-usa-products)

## Firms that cite its devices most
- ZheJiang Decans Medical Devices Co., Ltd.: 2 (https://510kreport.com/company/zhejiang-decans-medical-devices)
- Suzhou and Science & Technology Development Corp.: 1 (https://510kreport.com/company/suzhou-and-science-technology-development)
- Beijing Fule Science & Technology Development Co., Ltd.: 1 (https://510kreport.com/company/beijing-fule-science-technology-development)

## Its most-cited devices
- K172830: Double Medical Femoral Nail System (2018), cited by 2
- K221150: Advanced Bone Plate (2023), cited by 1
- K172828: Double Medical Cage System (2018), cited by 1
- K221088: Anatomic Bone Plate (2023), cited by 1
- K233078: Posterior Cervical Spine System (2023), cited by 1
- K220921: Metal Bone Screw (2022), cited by 1

## Recent decisions
- K252729: Universal Spinal System (Nov 18, 2025)
- K242348: Locking Screw,CoCrMo (Dec 4, 2024)
- K233078: Posterior Cervical Spine System (Nov 22, 2023)
- K223753: Cervical Plate System (Mar 14, 2023)
- K221150: Advanced Bone Plate (Jan 25, 2023)
- K221088: Anatomic Bone Plate (Jan 18, 2023)
- K221090: Metal Cannulated Screw (Jan 10, 2023)
- K221221: Advanced Intramedullary Nail System (Dec 21, 2022)

Source page: https://510kreport.com/company/double-medical-technology