Provident II Hip Stems

Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented

Globus Medical Inc.

The following data is part of a premarket notification filed by Globus Medical Inc. with the FDA for Provident Ii Hip Stems.

Pre-market Notification Details

Device IDK201733
510k NumberK201733
Device Name:Provident II Hip Stems
ClassificationProsthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Applicant Globus Medical Inc. 2560 General Armistead Ave. Audubon,  PA  19403
ContactJennifer Antonacci
CorrespondentJennifer Antonacci
Globus Medical Inc. 2560 General Armistead Ave. Audubon,  PA  19403
Product CodeLPH  
Subsequent Product CodeJDI
Subsequent Product CodeKWY
Subsequent Product CodeLWJ
Subsequent Product CodeLZO
Subsequent Product CodeOQH
Subsequent Product CodeOQI
CFR Regulation Number888.3358 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-25
Decision Date2021-07-14

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