SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone Cement

Cement, Bone, Vertebroplasty

Stryker Instruments

The following data is part of a premarket notification filed by Stryker Instruments with the FDA for Spinejack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex Hv Radiopaque Bone Cement.

Pre-market Notification Details

Device IDK211238
510k NumberK211238
Device Name:SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone Cement
ClassificationCement, Bone, Vertebroplasty
Applicant Stryker Instruments 1941 Stryker Way Portage,  MI  49002
ContactSusanne Galin
CorrespondentSusanne Galin
Stryker Instruments 1941 Stryker Way Portage,  MI  49002
Product CodeNDN  
Subsequent Product CodeLOD
Subsequent Product CodePML
CFR Regulation Number888.3027 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-04-26
Decision Date2021-06-25

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