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

Biomet Spine has 18 FDA 510(k) cleared orthopedic devices. Based in Warsaw, US.

Historical record: 18 cleared submissions from 2007 to 2016.

Browse the complete list of FDA 510(k) cleared orthopedic devices from this manufacturer. Filter by specialty or product code using the sidebar.

FDA 510(k) Regulatory Record - Biomet Spine
19 devices
1-19 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
Cleared Aug 07, 2008
PEEK-OPTIMA ALIF SPACER
K081636 · MAX
Orthopedic · 57d
Cleared Jul 02, 2008
SOLITAIRE ANTERIOR SPINAL SYSTEM
K081501 · OVD
Orthopedic · 34d
Cleared Jun 25, 2008
SOLITAIRE PEEK-OPTIMA ANTERIOR SPINAL SYSTEM
K081395 · OVD
Orthopedic · 37d
Cleared May 02, 2008
C-TEK MAXAN ANTERIOR CERVICAL PLATE SYSTEM
K080646 · KWQ
Orthopedic · 57d
Cleared Aug 06, 2007
POLARIS BE RODS
K071377 · KWP
Orthopedic · 81d
Cleared Jun 25, 2007
SMALL STATURE SPACERS
K063393 · MQP
Orthopedic · 228d
Cleared Apr 04, 2007
SPINAL STABILIZING SPHERE SYSTEM
K063139 · NVR
Orthopedic · 170d
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