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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 K212187
Device Name Restoration® Modular Hip System
Applicant
Howmedica Osteonics Corp., dba Stryker Orthopaedics
325 Corporate Dr.
Mahwah,  NJ  07430
Applicant Contact Margaret Klippel
Correspondent
Howmedica Osteonics Corp., dba Stryker Orthopaedics
325 Corporate Dr.
Mahwah,  NJ  07430
Correspondent Contact Margaret Klippel
Regulation Number888.3358
Classification Product Code
LPH  
Subsequent Product Codes
JDI   KWL   KWY   KWZ   LWJ  
LZO   MAY   MBL   MEH  
Date Received07/13/2021
Decision Date 03/01/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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