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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