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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 K992359
Device Name MRS-TITAN
Applicant
Rotec Medizintechnik GmbH
Am Muhlberg 31
Weisendorf,  DE D-91084
Applicant Contact ING ULRICH HOLZWARTH
Correspondent
Rotec Medizintechnik GmbH
Am Muhlberg 31
Weisendorf,  DE D-91084
Correspondent Contact ING ULRICH HOLZWARTH
Regulation Number888.3353
Classification Product Code
LZO  
Date Received07/14/1999
Decision Date 02/18/2000
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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