FDA 510(k) Application Details - K193092

Device Classification Name	Fastener, Fixation, Nondegradable, Soft Tissue   More FDA Info for this Device
510(K) Number	K193092
Device Name	Fastener, Fixation, Nondegradable, Soft Tissue
Applicant	Biomet Inc. 56 East Bell Drive, PO Box 587 Warsaw, IN 46582 US Other 510(k) Applications for this Company
Contact	Haley Pioch Other 510(k) Applications for this Contact
Regulation Number	888.3040   More FDA Info for this Regulation Number
Classification Product Code	MBI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/06/2019
Decision Date	01/02/2020
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