FDA 510(k) Application Details - K223294

Device Classification Name	Cement, Bone, Vertebroplasty   More FDA Info for this Device
510(K) Number	K223294
Device Name	Cement, Bone, Vertebroplasty
Applicant	Stryker Instruments 1941 Stryker Way Portage, MI 49002 US Other 510(k) Applications for this Company
Contact	Bruce Backlund Other 510(k) Applications for this Contact
Regulation Number	888.3027   More FDA Info for this Regulation Number
Classification Product Code	NDN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/26/2022
Decision Date	12/20/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review