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FDA 510(k) Application Details - K961413
Device Classification Name
Screw, Fixation, Bone
More FDA Info for this Device
510(K) Number
K961413
Device Name
Screw, Fixation, Bone
Applicant
SYNTHES (USA)
P.O. BOX 1766
1690 RUSSELL ROAD
PAOLI, PA 19301-1222 US
Other 510(k) Applications for this Company
Contact
ANGELA J SILVESTRI
Other 510(k) Applications for this Contact
Regulation Number
888.3040
More FDA Info for this Regulation Number
Classification Product Code
HWC
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/12/1996
Decision Date
08/07/1996
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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