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FDA 510(k) Application Details - K964416
Device Classification Name
Appliance, Fixation, Spinal Intervertebral Body
More FDA Info for this Device
510(K) Number
K964416
Device Name
Appliance, Fixation, Spinal Intervertebral Body
Applicant
SYNTHES (USA)
1690 RUSSELL RD.
P.O. BOX 1766
PAOLI, PA 19301 US
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Contact
DIANE T BROWN
Other 510(k) Applications for this Contact
Regulation Number
888.3060
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Classification Product Code
KWQ
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More FDA Info for this Product Code
Date Received
10/04/1996
Decision Date
03/17/1997
Decision
SN - Substantially Equivalent for Some Indications
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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