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FDA 510(k) Application Details - K071520
Device Classification Name
Fastener, Fixation, Nondegradable, Soft Tissue
More FDA Info for this Device
510(K) Number
K071520
Device Name
Fastener, Fixation, Nondegradable, Soft Tissue
Applicant
CORE ESSENCE ORTHOPAEDICS, LLC
301 OXFORD VALLEY RD.
SUITE 905B
YARDLEY, PA 19067 US
Other 510(k) Applications for this Company
Contact
SHAWN T HUXEL
Other 510(k) Applications for this Contact
Regulation Number
888.3040
More FDA Info for this Regulation Number
Classification Product Code
MBI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/04/2007
Decision Date
08/10/2007
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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