Medical Device Manufacturer · CN , Jiaxing

ZheJiang Decans Medical Devices Co., Ltd. - FDA 510(k) Cleared Devices

11 submissions · 11 cleared · Since 2024

Recent clearances: HERA Interlocking Intramedullary Nailing System, TAURUS Posterior Occipital-Cervico-Thoracic Spinal Systems, AQUA Laminoplasty Systems

11
Total
11
Cleared
0
Denied

FDA 510(k) Regulatory Record - ZheJiang Decans Medical Devices Co., Ltd. Orthopedic ✕

11 devices
1-11 of 11
Cleared Jun 16, 2026
HERA Interlocking Intramedullary Nailing System
K253046 · HSB
Orthopedic · 267d
Cleared Jun 02, 2026
TAURUS Posterior Occipital-Cervico-Thoracic Spinal Systems
K253195 · NKG
Orthopedic · 249d
Cleared May 27, 2026
AQUA Laminoplasty Systems
K252930 · NQW
Orthopedic · 254d
Cleared May 27, 2026
Dione PEEK Screw System
K253130 · MBI
Orthopedic · 244d
Cleared May 14, 2026
ARIES Anterior Cervical Plate Systems
K252776 · KWQ
Orthopedic · 254d
Cleared Apr 29, 2026
LEO Spinal System
K252542 · NKB
Orthopedic · 260d
Cleared Apr 20, 2026
SAGI Cervical Cage System
K253213 · OVE
Orthopedic · 203d
Cleared Apr 15, 2026
Uni-C Cervical Cage System
K252774 · OVE
Orthopedic · 225d
Cleared Jan 31, 2025
Crius PEEK Suture Anchor System (Thread-Fix Anchor)
K243665 · MBI
Orthopedic · 65d
Cleared Nov 04, 2024
Gemini Cervical Fusion Cage System
K242195 · ODP
Orthopedic · 101d
Cleared Oct 08, 2024
Gemini Medical Cage System
K242267 · MAX
Orthopedic · 68d
Filters
Filter by Specialty
All11 Orthopedic 11