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FDA 510(k) Application Details - K133036
Device Classification Name
Fastener, Fixation, Nondegradable, Soft Tissue
More FDA Info for this Device
510(K) Number
K133036
Device Name
Fastener, Fixation, Nondegradable, Soft Tissue
Applicant
AMENDIA INC.
11821 BRAMBLE COVE DRIVE
FT. MYERS, FL 33905 US
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Contact
RICH JANSEN
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
09/26/2013
Decision Date
03/06/2014
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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