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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 K000666
Device Name TC-PLUS SOLUTION KNEE
Applicant
Plus Orthopedics
3550 General Atomics Ct.
Bldg. #15-100
San Diego,  CA  92121
Applicant Contact HARTMUT LOCH
Correspondent
Plus Orthopedics
3550 General Atomics Ct.
Bldg. #15-100
San Diego,  CA  92121
Correspondent Contact HARTMUT LOCH
Regulation Number888.3560
Classification Product Code
JWH  
Date Received02/28/2000
Decision Date 10/13/2000
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
Recalls CDRH Recalls
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