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FDA 510(k) Application Details - K021979
Device Classification Name
Appliance, Fixation, Spinal Intervertebral Body
More FDA Info for this Device
510(K) Number
K021979
Device Name
Appliance, Fixation, Spinal Intervertebral Body
Applicant
SMISSON-CARTLEDGE
3722 AVE. SAUSALITO
IRVINE, CA 92606 US
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Contact
GRACE HOLLAND
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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
06/17/2002
Decision Date
06/27/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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