Suzhou Endophix Co., Ltd. - FDA 510(k) Cleared Devices
Recent clearances: Megaloop Button System, Javelot Ti Suture Anchor, Javelot Ti-D Suture Anchor, Javelot PK-S suture anchor, Javelot PK-S suture anchor (Knotless), Javelot PK-P suture anchor, Javelot PK-P suture anchor (Knotless), Javelot PK-L suture anchor (Knotless)
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Suzhou Endophix Co., Ltd. Orthopedic ✕
4 devices
Cleared
May 03, 2024
Megaloop Button System
Orthopedic
226d
Cleared
Nov 02, 2023
Javelot Ti Suture Anchor, Javelot Ti-D Suture Anchor
Orthopedic
57d
Cleared
Jun 07, 2023
Javelot PK-S suture anchor, Javelot PK-S suture anchor (Knotless), Javelot...
Orthopedic
61d
Cleared
May 23, 2023
Syntheface PEEK Interference Screw, Syntheface PEEK Screw Sheath
Orthopedic
54d