FDA 510(k) Application Details - K020279

Device Classification Name Orthosis, Spinal Pedicle Fixation

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510(K) Number K020279
Device Name Orthosis, Spinal Pedicle Fixation
Applicant FOREX CORP.
6132 SOUTH 380 WEST, SUITE 200
MURRAY, UT 84107-6988 US
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Contact ROBERT MALONE
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Regulation Number 888.3070

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Classification Product Code MNI
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Date Received 01/28/2002
Decision Date 06/20/2002
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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