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FDA 510(k) Applications Submitted by DARLA CHEW
FDA 510(k) Number
Submission Date
Device Name
Applicant
K100614
03/04/2010
HALLMARK ANTERIOR CERVCIAL PLATE SYSTEM, HALLMARK FIVE-LEVEL CERVICAL PLATES
BLACKSTONE MEDICAL, INC.
K111183
04/27/2011
ASCENT POSTERIOR OCCIPITAL THORACIC (POCT) SYSTEM (TITANIUM & COBALT CHROME RODS)
ORTHOFIX INC.
K111448
05/24/2011
ICON (TM) MODULAR PEDICLE SCREW SYSTEM
ORTHOFIX, INC.
K103111
10/21/2010
FORZA SPACER SYSTEM
ORTHOFIX INC.
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