FDA 510(k) Application Details - K021507

Device Classification Name Appliance, Fixation, Spinal Interlaminal

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510(K) Number K021507
Device Name Appliance, Fixation, Spinal Interlaminal
Applicant SPINE VISION, INC
3003 SUMMIT BLVD.
15TH FLOOR SUITE 1500
ATLANTA, GA 30319 US
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Contact LYNNETTE WHITAKER
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Regulation Number 888.3050

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Classification Product Code KWP
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Date Received 05/09/2002
Decision Date 08/01/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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