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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 K243192
Device Name iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi Coating
Applicant
Nextstep Arthopedix, LLC
1800 Triplett Blvd.
Akron,  OH  44306
Applicant Contact Garrett Spurgeon
Correspondent
Nextstep Arthopedix, LLC
1800 Triplett Blvd.
Akron,  OH  44306
Correspondent Contact Garrett Spurgeon
Regulation Number888.3358
Classification Product Code
LPH  
Subsequent Product Codes
KWY   LZO   MEH   OQG   OQI  
Date Received09/30/2024
Decision Date 06/05/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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