FDA 510(k) Application Details - K061482

Device Classification Name Appliance, Fixation, Spinal Intervertebral Body

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510(K) Number K061482
Device Name Appliance, Fixation, Spinal Intervertebral Body
Applicant ALTIVA CORP.
9800 SOUTHERN PINES BLVD.
SUITE I
CHARLOTTE, NC 28273 US
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Contact JOHN KAPITAN
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Regulation Number 888.3060

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Classification Product Code KWQ
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Date Received 05/30/2006
Decision Date 07/26/2006
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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