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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, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer
510(k) Number K193312
Device Name UNIKO PointCloud™ Knee Instruments
Applicant
Unik Orthopedics, Inc.
1701 Fortune Drive, Unit E
San Jose,  CA  95131
Applicant Contact Charlie Chi
Correspondent
Unik Orthopedics, Inc.
1701 Fortune Drive, Unit E
San Jose,  CA  95131
Correspondent Contact Charlie Chi
Regulation Number888.3565
Classification Product Code
MBH  
Subsequent Product Code
OOG  
Date Received11/29/2019
Decision Date 08/12/2020
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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