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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, Constrained, Cemented, Metal/Polymer
510(k) Number K003504
Device Name RT-PLUS MODULAR CEMENTED KNEE COMPONENTS
Applicant
Plus Orthopedics
3550 General Atomics Ct.
Bldg. #15-100
San Diego,  CA  92121 -1194
Applicant Contact HARMTMUT LOCH
Correspondent
Plus Orthopedics
3550 General Atomics Ct.
Bldg. #15-100
San Diego,  CA  92121 -1194
Correspondent Contact HARMTMUT LOCH
Regulation Number888.3510
Classification Product Code
KRO  
Date Received11/13/2000
Decision Date 05/11/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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