FDA 510(k) Application Details - K990959

Device Classification Name Appliance, Fixation, Spinal Intervertebral Body

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510(K) Number K990959
Device Name Appliance, Fixation, Spinal Intervertebral Body
Applicant SPINEOLOGY, INC.
1815 NORTHWESTERN AVE.
STILLWATER, MN 55082 US
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Contact PAMELA SNYDER
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Regulation Number 888.3060

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Classification Product Code KWQ
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Date Received 03/22/1999
Decision Date 12/27/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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