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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 K193233
Device Name Restoration® Modular Hip System
Applicant
Howmedica Osteonics Corp. (aka Stryker Orthopaedics)
325 Corporate Drive
Mahwah,  NJ  07430
Applicant Contact Nora O'Connor
Correspondent
Howmedica Osteonics Corp. (aka Stryker Orthopaedics)
325 Corporate Drive
Mahwah,  NJ  07430
Correspondent Contact Nora O'Connor
Regulation Number888.3358
Classification Product Code
LPH  
Subsequent Product Codes
JDI   KWL   KWY   KWZ   LWJ  
LZO   MAY   MBL   MEH  
Date Received11/25/2019
Decision Date 05/27/2020
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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