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FDA 510(k) Application Details - K960782
Device Classification Name
Component, Traction, Invasive
More FDA Info for this Device
510(K) Number
K960782
Device Name
Component, Traction, Invasive
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
JEC
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/26/1996
Decision Date
05/08/1996
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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