FDA 510(k) Application Details - K993808

Device Classification Name Orthosis, Spondyloisthesis Spinal Fixation

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510(K) Number K993808
Device Name Orthosis, Spondyloisthesis Spinal Fixation
Applicant INTERPORE CROSS INTL.
181 TECHNOLOGY DR.
IRVINE, CA 92618-2402 US
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Contact PROSIE REY-FESSLER
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Regulation Number 888.3070

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Classification Product Code MNH
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Date Received 11/10/1999
Decision Date 12/06/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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