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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 -1194
Applicant Contact HARTMUT LOCH
Correspondent
PLUS ORTHOPEDICS
3550 GENERAL ATOMICS CT.
BLDG. 15-100
SAN DIEGO,  CA  92121 -1194
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
Recalls CDRH Recalls
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