FDA 510(k) Application Details - K992885

Device Classification Name Appliance, Fixation, Spinal Interlaminal

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510(K) Number K992885
Device Name Appliance, Fixation, Spinal Interlaminal
Applicant OSTEOTECH, INC.
51 JAMES WAY
EATONTOWN, NJ 07724 US
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Contact JING ZHANG
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Regulation Number 888.3050

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Classification Product Code KWP
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Date Received 08/27/1999
Decision Date 11/19/1999
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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