Biomet Spine - FDA 510(k) Cleared Devices
Recent clearances: Alta ACDF System, Polaris Spinal System, Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System, Breckenridge Small Intervertebral Body Fusion System
19
Total
18
Cleared
0
Denied
FDA 510(k) Regulatory Record - Biomet Spine Orthopedic ✕
19 devices
Cleared
Jul 08, 2016
Alta ACDF System
Orthopedic
298d
Cleared
Nov 13, 2015
Polaris Spinal System
Orthopedic
120d
Cleared
Aug 12, 2015
Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System,...
Orthopedic
114d
Cleared
Jun 30, 2015
Lineum OCT Spine System
Orthopedic
54d
Cleared
Oct 09, 2014
BIOMET FUSION SYSTEM
Orthopedic
99d
Cleared
Jun 15, 2012
POLARIS SPINAL SYSTEM-BALLISTA SPINAL RODS
Orthopedic
63d
Cleared
Oct 17, 2011
ZYSTON STRAIGHT SPACER SYSTEM
Orthopedic
95d
Cleared
Feb 02, 2011
POLARIS SPINAL SYSTEM
Orthopedic
75d
Cleared
Mar 09, 2010
SOLITAIRE AND SOLITAIRE PEEK ANTERIOR SPINAL SYSTEM
Orthopedic
106d
Cleared
Jul 14, 2009
5.5 POLARIS SPINAL SYSTEM
Orthopedic
91d
Cleared
Apr 02, 2009
INTERGRO DBM
Orthopedic
191d
Cleared
Oct 07, 2008
SYNERGY SPINAL SYSTEM (6.35 POLARIS)
Orthopedic
90d