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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 K002324
Device Name MODIFIED TO MODULAR FR SEVERE BONE LOSS TRAUMA
Applicant
Sulzermedica
9900 Spectrum Dr.
Austin,  TX  78717
Applicant Contact FRANCES E HARRISON
Correspondent
Sulzermedica
9900 Spectrum Dr.
Austin,  TX  78717
Correspondent Contact FRANCES E HARRISON
Regulation Number888.3350
Classification Product Code
JDI  
Subsequent Product Codes
KRO   LZO  
Date Received07/31/2000
Decision Date 08/24/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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