Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable Spinal System

Bone Cement, Posterior Screw Augmentation

Stryker Corporation

The following data is part of a premarket notification filed by Stryker Corporation with the FDA for Vertaplex Hv High Viscosity Radiopaque Bone Cement; Es2 Augmentable Spinal System.

Pre-market Notification Details

Device IDK192818
510k NumberK192818
Device Name:Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable Spinal System
ClassificationBone Cement, Posterior Screw Augmentation
Applicant Stryker Corporation 4100 E. Milham Avenue Kalamazoo,  MI  49001
ContactKristi Ashton
CorrespondentKristi Ashton
Stryker Corporation 4100 E. Milham Avenue Kalamazoo,  MI  49001
Product CodePML  
Subsequent Product CodeMNI
Subsequent Product CodeNDN
Subsequent Product CodeNKB
CFR Regulation Number888.3027 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-10-01
Decision Date2020-03-31
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.