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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, cemented
510(k) Number K213701
Device Name Exeter® X3® RimFit® Cup
Applicant
Howmedica Osteonics Corp., dba Stryker Orthopaedics
325 Corporate Drive
Mahwah,  NJ  07430
Applicant Contact Lin Song
Correspondent
Howmedica Osteonics Corp., dba Stryker Orthopaedics
325 Corporate Drive
Mahwah,  NJ  07430
Correspondent Contact Lin Song
Regulation Number888.3350
Classification Product Code
JDI  
Subsequent Product Codes
JDG   KWY   LZO  
Date Received11/24/2021
Decision Date 02/01/2022
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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