FDA 510(k) Application Details - K212306

Device Classification Name	More FDA Info for this Device
510(K) Number	K212306
Device Name	Tapestry Biointegrative Implant
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	More FDA Info for this Regulation Number
Classification Product Code	OWY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/23/2021
Decision Date	11/02/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review