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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Knee Arthroplasty Implantation System
510(k) Number K230850
Device Name United Orthopedic Knee Patient Specific Instrumentation
Applicant
Enhatch, Inc.
226 Boulevard
Hasbrouck Heights,  NJ  07604
Applicant Contact Monica Williams
Correspondent
Enhatch, Inc.
226 Boulevard
Hasbrouck Heights,  NJ  07604
Correspondent Contact Monica Williams
Regulation Number888.3560
Classification Product Code
OOG  
Subsequent Product Codes
LLZ   PBF  
Date Received03/28/2023
Decision Date 12/20/2023
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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