FDA 510(k) Application Details - K220838

Device Classification Name	Cement Obturator   More FDA Info for this Device
510(K) Number	K220838
Device Name	Cement Obturator
Applicant	Howmedica Osteonics, dba Stryker Orthopaedics 325 Corporate Drive Mahwah, NJ 07430 US Other 510(k) Applications for this Company
Contact	Margaret Klippel Other 510(k) Applications for this Contact
Regulation Number	878.3300   More FDA Info for this Regulation Number
Classification Product Code	LZN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/22/2022
Decision Date	05/20/2022
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