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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, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
510(k) Number K240327
Device Name UNIKO PointCloud™ Knee Instruments
Applicant
Unik Orthopedics, Inc.
701 Fortune Dr., Unit E
San Jose,  CA  95131
Applicant Contact Charlie Chi
Correspondent
Unik Orthopedics, Inc.
701 Fortune Dr., Unit E
San Jose,  CA  95131
Correspondent Contact Charlie Chi
Regulation Number888.3560
Classification Product Code
JWH  
Subsequent Product Codes
MBH   OOG  
Date Received02/02/2024
Decision Date 06/27/2024
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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