FDA 510(k) Application Details - K221731

Device Classification Name Fastener, Fixation, Nondegradable, Soft Tissue

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510(K) Number K221731
Device Name Fastener, Fixation, Nondegradable, Soft Tissue
Applicant T.A.G. Medical Products Corporation, Ltd

Gaaton 2513000 IL
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Contact Shlomi Dines
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Regulation Number 888.3040

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Classification Product Code MBI
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Date Received 06/15/2022
Decision Date 09/07/2022
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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