FDA 510(k) Application Details - K203495

Device Classification Name	Fastener, Fixation, Biodegradable, Soft Tissue   More FDA Info for this Device
510(K) Number	K203495
Device Name	Fastener, Fixation, Biodegradable, Soft Tissue
Applicant	Arthrex Inc. 1370 Creekside Boulevard Naples, FL 34108 US Other 510(k) Applications for this Company
Contact	Kelsey Roberts Other 510(k) Applications for this Contact
Regulation Number	888.3030   More FDA Info for this Regulation Number
Classification Product Code	MAI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/27/2020
Decision Date	04/19/2021
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