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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/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
510(k) Number K213129
Device Name Restoration Modular 115mm Conical Distal Stem
Applicant
Howmedica Osteonics Corp., Dba Stryker Orthopaedics
325 Corporate Dr.
Malwah,  NJ  07430
Applicant Contact Allison Byrne
Correspondent
Howmedica Osteonics Corp., Dba Stryker Orthopaedics
325 Corporate Dr.
Malwah,  NJ  07430
Correspondent Contact Allison Byrne
Regulation Number888.3353
Classification Product Code
LZO  
Subsequent Product Codes
JDI   KWZ   LPH   MAY   MBL  
MEH  
Date Received09/27/2021
Decision Date 12/21/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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