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FDA 510(k) Application Details - K974706
Device Classification Name
Appliance, Fixation, Spinal Intervertebral Body
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510(K) Number
K974706
Device Name
Appliance, Fixation, Spinal Intervertebral Body
Applicant
AESCULAP, INC.
1000 GATEWAY BLVD.
SOUTH SAN FRANCISCO, CA 94080 US
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Contact
LIA SPASARO
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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
12/16/1997
Decision Date
03/13/1998
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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