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FDA 510(k) Applications Submitted by BIOMET SPINE
FDA 510(k) Number
Submission Date
Device Name
Applicant
K151064
04/20/2015
Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System, Breckenridge Small Intervertebral Body Fusion System
BIOMET SPINE
K151974
07/16/2015
Polaris Spinal System
BIOMET SPINE
K152622
09/14/2015
Alta ACDF System
BIOMET SPINE
K071377
05/17/2007
POLARIS BE RODS
BIOMET SPINE
K080646
03/06/2008
C-TEK MAXAN ANTERIOR CERVICAL PLATE SYSTEM
BIOMET SPINE
K112014
07/14/2011
ZYSTON STRAIGHT SPACER SYSTEM
BIOMET SPINE
K082793
09/23/2008
INTERGRO DBM
BIOMET SPINE
K063139
10/16/2006
SPINAL STABILIZING SPHERE SYSTEM
BIOMET SPINE
K151224
05/07/2015
Lineum OCT Spine System
BIOMET SPINE
K063393
11/09/2006
SMALL STATURE SPACERS
BIOMET SPINE
K141791
07/02/2014
BIOMET FUSION SYSTEM
BIOMET SPINE
K121130
04/13/2012
POLARIS SPINAL SYSTEM-BALLISTA SPINAL RODS
BIOMET SPINE
K091067
04/14/2009
5.5 POLARIS SPINAL SYSTEM
BIOMET SPINE
K081395
05/19/2008
SOLITAIRE PEEK-OPTIMA ANTERIOR SPINAL SYSTEM
BIOMET SPINE
K081501
05/29/2008
SOLITAIRE ANTERIOR SPINAL SYSTEM
BIOMET SPINE
K081636
06/11/2008
PEEK-OPTIMA ALIF SPACER
BIOMET SPINE
K081952
07/09/2008
SYNERGY SPINAL SYSTEM (6.35 POLARIS)
BIOMET SPINE
K103393
11/19/2010
POLARIS SPINAL SYSTEM
BIOMET SPINE
K093629
11/23/2009
SOLITAIRE AND SOLITAIRE PEEK ANTERIOR SPINAL SYSTEM
BIOMET SPINE
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