FDA 510(k) Application Details - K022726

Device Classification Name Screw, Fixation, Bone

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510(K) Number K022726
Device Name Screw, Fixation, Bone
Applicant PIONEER SURGICAL TECHNOLOGY
375 RIVER PARK CIRCLE
MARQUETTE, MI 49855-0627 US
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Contact KATHY MORAN
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Regulation Number 888.3040

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Classification Product Code HWC
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Date Received 08/16/2002
Decision Date 09/06/2002
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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