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Biomet Spine

FDA 510(k) & PMA Approved Devices — 15 products

Total Devices15
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K152622 Alta ACDF SystemOVE2016-07-08 View
510(k) K121130 POLARIS SPINAL SYSTEM-BALLISTA SPINAL RODSNKB2012-06-15 View
510(k) K112014 ZYSTON STRAIGHT SPACER SYSTEMMAX2011-10-17 View
510(k) K103393 POLARIS SPINAL SYSTEMKWQ2011-02-02 View
510(k) K093629 SOLITAIRE AND SOLITAIRE PEEK ANTERIOR SPINAL SYSTEMOVD2010-03-09 View
510(k) K091067 5.5 POLARIS SPINAL SYSTEMNKB2009-07-14 View
510(k) K082793 INTERGRO DBMMQV2009-04-02 View
510(k) K081952 SYNERGY SPINAL SYSTEM (6.35 POLARIS)NKB2008-10-07 View
510(k) K081636 PEEK-OPTIMA ALIF SPACERMAX2008-08-07 View
510(k) K081501 SOLITAIRE ANTERIOR SPINAL SYSTEMOVD2008-07-02 View
510(k) K081395 SOLITAIRE PEEK-OPTIMA ANTERIOR SPINAL SYSTEMOVD2008-06-25 View
510(k) K080646 C-TEK MAXAN ANTERIOR CERVICAL PLATE SYSTEMKWQ2008-05-02 View
510(k) K071377 POLARIS BE RODSKWP2007-08-06 View
510(k) K063393 SMALL STATURE SPACERSMQP2007-06-25 View
510(k) K063139 SPINAL STABILIZING SPHERE SYSTEMNVR2007-04-04 View
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