ZheJiang Decans Medical Devices Co., Ltd. - FDA 510(k) Cleared Devices
Recent clearances: TAURUS Posterior Occipital-Cervico-Thoracic Spinal Systems, AQUA Laminoplasty Systems, Dione PEEK Screw System
11
Total
11
Cleared
0
Denied
FDA 510(k) Regulatory Record - ZheJiang Decans Medical Devices Co., Ltd. Orthopedic ✕
11 devices
Cleared
Jun 16, 2026
HERA Interlocking Intramedullary Nailing System
Orthopedic
267d
Cleared
Jun 02, 2026
TAURUS Posterior Occipital-Cervico-Thoracic Spinal Systems
Orthopedic
249d
Cleared
May 27, 2026
AQUA Laminoplasty Systems
Orthopedic
254d
Cleared
May 27, 2026
Dione PEEK Screw System
Orthopedic
244d
Cleared
May 14, 2026
ARIES Anterior Cervical Plate Systems
Orthopedic
254d
Cleared
Apr 29, 2026
LEO Spinal System
Orthopedic
260d
Cleared
Apr 20, 2026
SAGI Cervical Cage System
Orthopedic
203d
Cleared
Apr 15, 2026
Uni-C Cervical Cage System
Orthopedic
225d
Cleared
Jan 31, 2025
Crius PEEK Suture Anchor System (Thread-Fix Anchor)
Orthopedic
65d
Cleared
Nov 04, 2024
Gemini Cervical Fusion Cage System
Orthopedic
101d
Cleared
Oct 08, 2024
Gemini Medical Cage System
Orthopedic
68d