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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
510(k) Number K021178
Device Name SL-PLUS LATERALIZED STEM
Applicant
Plus Orthopedics
6055 Lusk Blvd.
San Diego,  CA  92121
Applicant Contact HARTMUT LOCH
Correspondent
Plus Orthopedics
6055 Lusk Blvd.
San Diego,  CA  92121
Correspondent Contact HARTMUT LOCH
Regulation Number888.3350
Classification Product Code
JDI  
Subsequent Product Code
LWJ  
Date Received04/15/2002
Decision Date 05/14/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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