FDA 510(k) Application Details - K020377

Device Classification Name Screw, Fixation, Bone

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510(K) Number K020377
Device Name Screw, Fixation, Bone
Applicant LINVATEC CORP.
11311 CONCEPT BLVD.
LARGO, FL 33773-4908 US
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Contact LAURA D SENEFF
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Regulation Number 888.3040

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Classification Product Code HWC
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Date Received 02/05/2002
Decision Date 05/06/2002
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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