FDA 510(k) Application Details - K110473

Device Classification Name Fastener, Fixation, Nondegradable, Soft Tissue

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510(K) Number K110473
Device Name Fastener, Fixation, Nondegradable, Soft Tissue
Applicant PIVOT MEDICAL
247 HUMBOLDT CT.
SUNNYVALE, CA 94089 US
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Contact Jon Cook
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Regulation Number 888.3040

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Classification Product Code MBI
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Date Received 02/18/2011
Decision Date 05/25/2011
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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