Restoration Anatomic Shell

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

Howmedica Osteonics Corp. A.k.a. Stryker Orthopaedics

The following data is part of a premarket notification filed by Howmedica Osteonics Corp. A.k.a. Stryker Orthopaedics with the FDA for Restoration Anatomic Shell.

Pre-market Notification Details

Device IDK210893
510k NumberK210893
Device Name:Restoration Anatomic Shell
ClassificationProsthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Applicant Howmedica Osteonics Corp. A.k.a. Stryker Orthopaedics 325 Corporate Drive Mahwah,  NJ  07430
ContactAlexandra Kirby
CorrespondentAlexandra Kirby
Howmedica Osteonics Corp. A.k.a. Stryker Orthopaedics 325 Corporate Drive Mahwah,  NJ  07430
Product CodeLPH  
CFR Regulation Number888.3358 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-03-25
Decision Date2021-04-22

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