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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name prosthesis, hip, semi-constrained, metal/polymer, porous uncemented
510(k) Number K210893
Device Name Restoration Anatomic Shell
Applicant
Howmedica Osteonics Corp. a.k.a. Stryker Orthopaedics
325 Corporate Drive
Mahwah,  NJ  07430
Applicant Contact Alexandra Kirby
Correspondent
Howmedica Osteonics Corp. a.k.a. Stryker Orthopaedics
325 Corporate Drive
Mahwah,  NJ  07430
Correspondent Contact Alexandra Kirby
Regulation Number888.3358
Classification Product Code
LPH  
Date Received03/25/2021
Decision Date 04/22/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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