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FDA 510(k) Application Details - K083070
Device Classification Name
Fastener, Fixation, Nondegradable, Soft Tissue
More FDA Info for this Device
510(K) Number
K083070
Device Name
Fastener, Fixation, Nondegradable, Soft Tissue
Applicant
BIOMET SPORTS MEDICINE
P.O. BOX 587
WARSAW, IN 46581-0587 US
Other 510(k) Applications for this Company
Contact
ROBERT FRIDDLE
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
10/15/2008
Decision Date
12/16/2008
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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