FDA 510(k) Application Details - K192818

Device Classification Name	More FDA Info for this Device
510(K) Number	K192818
Device Name	Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable Spinal System
Applicant	Stryker Corporation 4100 E. Milham Avenue Kalamazoo, MI 49001 US Other 510(k) Applications for this Company
Contact	Kristi Ashton Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PML Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/01/2019
Decision Date	03/31/2020
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