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FDA 510(k) Application Details - K962894
Device Classification Name
Plate, Fixation, Bone
More FDA Info for this Device
510(K) Number
K962894
Device Name
Plate, Fixation, Bone
Applicant
SYNTHES (USA)
1690 RUSSELL RD.
POST OFFICE BOX 1766
PAOLI, PA 19301 US
Other 510(k) Applications for this Company
Contact
ANGELA J SILVESTRI
Other 510(k) Applications for this Contact
Regulation Number
888.3030
More FDA Info for this Regulation Number
Classification Product Code
HRS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/25/1996
Decision Date
12/17/1996
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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