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FDA 510(k) Application Details - K112965
Device Classification Name
Fastener, Fixation, Nondegradable, Soft Tissue
More FDA Info for this Device
510(K) Number
K112965
Device Name
Fastener, Fixation, Nondegradable, Soft Tissue
Applicant
LINVATEC CORPORATION D/B/A CONMED LINVATEC
11311 Concept Boulevard
LARGO, FL 33773 US
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Contact
ASHLEA RICCI
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
10/05/2011
Decision Date
11/02/2011
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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