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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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