FDA 510(k) Application Details - K103173

Device Classification Name Filler, Bone Void, Calcium Compound

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510(K) Number K103173
Device Name Filler, Bone Void, Calcium Compound
Applicant ORTHOVITA, INC.
45 GREAT VALLEY PKWY.
MALVERN, PA 19355 US
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Contact DEBORAH L JACKSON
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Regulation Number 888.3045

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Classification Product Code MQV
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Date Received 10/28/2010
Decision Date 02/07/2011
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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