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FDA 510(k) Application Details - K024326
Device Classification Name
Appliance, Fixation, Spinal Intervertebral Body
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510(K) Number
K024326
Device Name
Appliance, Fixation, Spinal Intervertebral Body
Applicant
SPINAL CONCEPTS, INC.
5301 RIATA PARK COURT
BLDG F
AUSTIN, TX 78727 US
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Contact
LISA PETERSON
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
12/26/2002
Decision Date
01/23/2003
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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