FDA 510(k) Application Details - K171060

Device Classification Name Fastener, Fixation, Nondegradable, Soft Tissue

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510(K) Number K171060
Device Name Fastener, Fixation, Nondegradable, Soft Tissue
Applicant Riverpoint Medical
825 NE 25TH Avenue
Portland, OR 97232 US
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Contact Nathan Cook
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Regulation Number 888.3040

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Classification Product Code MBI
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Date Received 04/10/2017
Decision Date 06/02/2017
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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