FDA 510(k) Application Details - K213958

Device Classification Name	Fastener, Fixation, Biodegradable, Soft Tissue   More FDA Info for this Device
510(K) Number	K213958
Device Name	Fastener, Fixation, Biodegradable, Soft Tissue
Applicant	Embody, Inc. 4211 Monarch Way, Suite 500 Norfolk, VA 23508 US Other 510(k) Applications for this Company
Contact	Brianna Schehr 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	12/17/2021
Decision Date	04/08/2022
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