Inion , Ltd. - FDA 510(k) Cleared Devices
Recent clearances: INION SPINAL GRAFT CONTAINMENT SYSTEM, INION CPS/OTPS FREEDOMPLATE, MODIFICATION TO INION OTPS BIODEGRADABLE FIXATION SYSTEM
23
Total
22
Cleared
0
Denied
FDA 510(k) Regulatory Record - Inion , Ltd. Orthopedic ✕
14 devices
Cleared
Jul 11, 2008
INION SPINAL GRAFT CONTAINMENT SYSTEM
Orthopedic
375d
Cleared
Jan 23, 2007
INION CPS/OTPS FREEDOMPLATE
Orthopedic
71d
Cleared
Oct 04, 2006
MODIFICATION TO INION OTPS BIODEGRADABLE FIXATION SYSTEM
Orthopedic
29d
Cleared
Mar 13, 2006
INION HEXALON BIODEGRADABLE ACL/PCL SCREW
Orthopedic
26d
Cleared
Nov 25, 2005
INION S-1 BIODEGRADABLE ANTERIOR CERVICAL FUSION SYSTEM
Orthopedic
143d
Cleared
Nov 16, 2005
INION OTPS BIODEGRADABLE DISTAL RADIUS PLATE
Orthopedic
54d
Cleared
Mar 07, 2005
MODIFICATION TO: INION OTPS BIODEGRADABLE PIN
Orthopedic
28d
Cleared
Feb 18, 2005
INION OTPS BIODEGRADABLE MINI PLATING SYSTEM
Orthopedic
95d
Cleared
Aug 16, 2004
INION TRINION BIODEGRADABLE MENISCUS SCREW
Orthopedic
441d
Cleared
Mar 01, 2004
INION OTPS BIODEGRADABLE MESH PLATING SYSTEM
Orthopedic
250d
Cleared
Aug 28, 2003
INION OTPS BIODEGRADABLE PIN
Orthopedic
87d
Cleared
Jun 19, 2003
INION OTPS BIODEGRADABLE FIXATON SYSTEM
Orthopedic
87d
Cleared
May 30, 2003
INION OTPS BIODEGRADABLE MINI PLATING SYSTEM
Orthopedic
190d
Cleared
Jul 17, 2002
INION HEXALON BIODEGRADABLE ACL/PCL SCREW
Orthopedic
86d