Medical Device Manufacturer · US , Warsaw , IN

Biomet Spine - FDA 510(k) Cleared Devices

19 submissions · 18 cleared · Since 2007
19
Total
18
Cleared
0
Denied
FDA 510(k) Regulatory Record - Biomet Spine Orthopedic ✕
19 devices
1-12 of 19
Cleared Jul 08, 2016
Alta ACDF System
K152622 · OVE
Orthopedic · 298d
Cleared Nov 13, 2015
Polaris Spinal System
K151974 · NKB
Orthopedic · 120d
Cleared Aug 12, 2015
Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System,...
K151064 · OVE
Orthopedic · 114d
Cleared Jun 30, 2015
Lineum OCT Spine System
K151224 · NKG
Orthopedic · 54d
Cleared Oct 09, 2014
BIOMET FUSION SYSTEM
K141791 · OVD
Orthopedic · 99d
Cleared Jun 15, 2012
POLARIS SPINAL SYSTEM-BALLISTA SPINAL RODS
K121130 · NKB
Orthopedic · 63d
Cleared Oct 17, 2011
ZYSTON STRAIGHT SPACER SYSTEM
K112014 · MAX
Orthopedic · 95d
Cleared Feb 02, 2011
POLARIS SPINAL SYSTEM
K103393 · KWQ
Orthopedic · 75d
Cleared Mar 09, 2010
SOLITAIRE AND SOLITAIRE PEEK ANTERIOR SPINAL SYSTEM
K093629 · OVD
Orthopedic · 106d
Cleared Jul 14, 2009
5.5 POLARIS SPINAL SYSTEM
K091067 · NKB
Orthopedic · 91d
Cleared Apr 02, 2009
INTERGRO DBM
K082793 · MQV
Orthopedic · 191d
Cleared Oct 07, 2008
SYNERGY SPINAL SYSTEM (6.35 POLARIS)
K081952 · NKB
Orthopedic · 90d
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