Amendia, Inc. - FDA 510(k) Cleared Devices
Recent clearances: Amendia Interbody Fusion Devices, Overwatch Spine System, Savannah-T® Pedicle Screw System
16
Total
16
Cleared
0
Denied
FDA 510(k) Regulatory Record - Amendia, Inc. Orthopedic ✕
16 devices
Cleared
Nov 08, 2016
Amendia Interbody Fusion Devices
Orthopedic
218d
Cleared
Oct 13, 2016
Overwatch Spine System
Orthopedic
100d
Cleared
Jul 08, 2016
Savannah-T® Pedicle Screw System
Orthopedic
280d
Cleared
Apr 27, 2016
Syzygy Stabilization System
Orthopedic
177d
Cleared
Feb 18, 2016
Optimus ALIF System
Orthopedic
15d
Cleared
Jan 14, 2016
Amendia Stand-Alone Cervical System
Orthopedic
98d
Cleared
Jan 06, 2016
Amendia Interbody Fusion Devices
Orthopedic
233d
Cleared
Dec 22, 2015
Rectangular Corpectomy Cage
Orthopedic
116d
Cleared
Oct 15, 2015
Amendia Cervical Plate System
Orthopedic
48d
Cleared
Sep 10, 2015
Amendia Interbody Fusion Devices
Orthopedic
115d
Cleared
Aug 10, 2015
Omega LIF System
Orthopedic
173d
Cleared
Mar 06, 2014
APOLLO SUTURE ANCHOR SYSTEM AND TITAN SCREWS
Orthopedic
161d
Cleared
Feb 11, 2014
SAVANNAH-T, REDUCTION, SAVANNAH-T, HIGH-TOP, SAVANNAH-T, MONOAXIAL MID-TOP,...
Orthopedic
146d
Cleared
Dec 06, 2011
SPARTAN S3 FACET SYSTEM
Orthopedic
56d
Cleared
May 13, 2010
DIAMOND ANTERIOR CERVICAL PLATE SYSTEM
Orthopedic
104d
Cleared
Nov 17, 2009
SPARTAN S3 FACET SYSTEM
Orthopedic
89d