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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 K220483
Device Name Platform® Acetabular System
Applicant
Total Joint Orthopedics, Inc.
1567 E. Stratford Avenue
Salt Lake City,  UT  84106
Applicant Contact Chris Weaber
Correspondent
Mcra LLC.
803 7th Street NW
Washington,  DC  20001
Correspondent Contact Holly Rhodes
Regulation Number888.3353
Classification Product Code
LZO  
Subsequent Product Codes
LPH   MBL   OQG  
Date Received02/18/2022
Decision Date 09/23/2022
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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