FDA 510(k) Application Details - K231208

Device Classification Name	Fastener, Plate, Cranioplasty   More FDA Info for this Device
510(K) Number	K231208
Device Name	Fastener, Plate, Cranioplasty
Applicant	Stryker Leibinger GmbH & Co. KG Boetzinger Strasse 41 D-79111 Freiburg DE Other 510(k) Applications for this Company
Contact	Gregory Gohl Other 510(k) Applications for this Contact
Regulation Number	882.5360   More FDA Info for this Regulation Number
Classification Product Code	HBW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/27/2023
Decision Date	08/14/2023
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