FDA 510(k) Application Details - K212943

Device Classification Name	Dura Substitute   More FDA Info for this Device
510(K) Number	K212943
Device Name	Dura Substitute
Applicant	Synthes (USA) products, LLC 1230 Wilson Dr. West Chester, PA 19380 US Other 510(k) Applications for this Company
Contact	Doug Steinberger Other 510(k) Applications for this Contact
Regulation Number	882.5910   More FDA Info for this Regulation Number
Classification Product Code	GXQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/15/2021
Decision Date	01/28/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review