FDA 510(k) Application Details - K221468

Device Classification Name	Fastener, Fixation, Biodegradable, Soft Tissue   More FDA Info for this Device
510(K) Number	K221468
Device Name	Fastener, Fixation, Biodegradable, Soft Tissue
Applicant	Acuitive Technologies, Inc. 50 Commerce Drive Allendale, NJ 07401 US Other 510(k) Applications for this Company
Contact	Matthew Poggie 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	05/20/2022
Decision Date	02/14/2023
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