FDA 510(k) Applications Submitted by Regina Holmes

FDA 510(k) Number Submission Date Device Name Applicant
K100107 01/14/2010 SMITH & NEPHEW SURESHOT DISTAL TARGETING SYSTEM V2.0 SMITH & NEPHEW, INC.
K140454 02/24/2014 NAVIGATED CD HORIZON SOLERA SCREWDRIVER/TAPS MEDTRONIC SOFAMOR DANEK USA, INC.
K110562 02/28/2011 TELAMON PEEK SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA
K111264 05/04/2011 CORNERSTONE (R) PSR CERVICAL FUSION SYSTEM MEDTRONIC SOFAMOR DANEK USA
K131425 05/17/2013 NAVIGATED CAPSTONE TRIALS, CLYDESDALE TRIALS, CAPSTONE & CLYDESDALE INSERTER MEDTRONIC NAVIGATION, INC.
K092497 08/14/2009 SMITH & NEPHEW PIGALILEO SCREW TARGETING SYSTEM, VERSION 1.1 SMITH & NEPHEW, INC.
K162793 10/04/2016 RHYTHMIA HDx Mapping System Boston Scientific Corporation


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