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FDA 510(k) Application Details - K990965
Device Classification Name
Appliance, Fixation, Spinal Interlaminal
More FDA Info for this Device
510(K) Number
K990965
Device Name
Appliance, Fixation, Spinal Interlaminal
Applicant
SYNTHES (USA)
P.O. BOX 0548
1690 RUSSELL ROAD
PAOLI, PA 19301 US
Other 510(k) Applications for this Company
Contact
JONATHAN GILBERT
Other 510(k) Applications for this Contact
Regulation Number
888.3050
More FDA Info for this Regulation Number
Classification Product Code
KWP
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/22/1999
Decision Date
07/01/1999
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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