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FDA 510(k) Application Details - K013979
Device Classification Name
Appliance, Fixation, Spinal Intervertebral Body
More FDA Info for this Device
510(K) Number
K013979
Device Name
Appliance, Fixation, Spinal Intervertebral Body
Applicant
SPINAL CONCEPTS, INC.
12012 TECHNOLOGY BLVD., #100
AUSTIN, TX 78727 US
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Contact
DAVID M HOOPER
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
12/03/2001
Decision Date
02/13/2002
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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