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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/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
510(k) Number K990261
Device Name PLUS CERAMIC HEAD PROSTHESES (ALUMINA AND ZIRKONIA)
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 Number888.3353
Classification Product Code
LZO  
Date Received01/27/1999
Decision Date 08/27/1999
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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