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FDA 510(k) Applications Submitted by MARY BIGGERS, RAC
FDA 510(k) Number
Submission Date
Device Name
Applicant
K970400
02/03/1997
BONE SOURCE HYDROXYAPATITE
ORTHOFIX, INC.
K110805
03/23/2011
GUIDED GROWTH SYSTEM EIGHT-PLATE, QUAD-PLATE (STAINLESS STEEL)
ORTHOFIX INC.
K031219
04/17/2003
MODIFICATION TO ISKD (INTRAMEDULLARY SKELETAL KINETIC DISTRACTOR)
ORTHOFIX, INC.
K953339
07/17/1995
BONESOURCE HYDROXYAPATITE CEMENT (HAC)
OSTEOGENICS, INC.
K102201
08/04/2010
CONTOURS LAPIDUS PLATING SYSTEM
ORTHOFIX INC.
K093442
11/05/2009
GUIDED GROWTH SYSTEM
ORTHOFIX INC.
K964537
11/12/1996
BONESOURCE HYDROXYAPATITE CEMENT (HAC)
OSTEOGENICS, INC.
K101936
07/12/2010
CONTOURS VSP III VOLAR PLATING SYSTEM
ORTHOFIX, INC.
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