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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 K240783
Device Name Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip Stems
Applicant
Smith & Nephew, Inc.
1450 E. Brooks Rd.
Memphis,  TN  38116
Applicant Contact Laurel Arrigona
Correspondent
Smith & Nephew, Inc.
1450 E. Brooks Rd.
Memphis,  TN  38116
Correspondent Contact Laurel Arrigona
Regulation Number888.3350
Classification Product Code
JDI  
Subsequent Product Codes
KWY   KWZ   LPH   LWJ   LZO  
MBL   MEH  
Date Received03/21/2024
Decision Date 10/21/2024
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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