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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
510(k) Number K212870
Device Name TLC Unicompartmental Knee System
Applicant
Signature Orthopaedics Pty, Ltd.
7 Sirius Rd.
Lane Cove West,  AU 2066
Applicant Contact Declan Brazil
Correspondent
Signature Orthopaedics Pty, Ltd.
7 Sirius Rd.
Lane Cove West,  AU 2066
Correspondent Contact Declan Brazil
Regulation Number888.3520
Classification Product Code
HSX  
Date Received09/09/2021
Decision Date 06/16/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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