FDA 510(k) Application Details - K032102

Device Classification Name Appliance, Fixation, Spinal Intervertebral Body

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510(K) Number K032102
Device Name Appliance, Fixation, Spinal Intervertebral Body
Applicant VERTELINK CORPORATION
3722 AVE. SAUSALITO
IRVINE, CA 92606 US
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Contact GREG HOLLAND
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Regulation Number 888.3060

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Classification Product Code KWQ
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Date Received 07/08/2003
Decision Date 12/12/2003
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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