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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, Uncemented
510(k) Number K994126
Device Name MODULAR-PLUS REVISION STEM
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 Number888.3360
Classification Product Code
LWJ  
Date Received12/07/1999
Decision Date 05/04/2000
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
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