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FDA 510(k) Application Details - K973060
Device Classification Name
Appliance, Fixation, Spinal Intervertebral Body
More FDA Info for this Device
510(K) Number
K973060
Device Name
Appliance, Fixation, Spinal Intervertebral Body
Applicant
DEPUY, INC.
700 ORTHOPAEDIC DR.
P.O. BOX 988
WARSAW, IN 46581-0988 US
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Contact
JOHN D VAN VLEET
Other 510(k) Applications for this Contact
Regulation Number
888.3060
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Classification Product Code
KWQ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/18/1997
Decision Date
11/03/1997
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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