FDA 510(k) Application Details - K203267

Device Classification Name	More FDA Info for this Device
510(K) Number	K203267
Device Name	The BioBrace Implant
Applicant	Biorez, Inc. 470 James Street, Suite 14 New Haven, CT 06513 US Other 510(k) Applications for this Company
Contact	Kevin Rocco Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OWT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/05/2020
Decision Date	04/30/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review