FDA 510(k) Application Details - K014185

Device Classification Name Screw, Fixation, Bone

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510(K) Number K014185
Device Name Screw, Fixation, Bone
Applicant ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
333 WEST 6TH ST., SUITE 202
SAN PEDRO, CA 90731 US
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Contact PAUL DONER
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Regulation Number 888.3040

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Classification Product Code HWC
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Date Received 12/20/2001
Decision Date 02/13/2002
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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