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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, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
510(k) Number K922621
Device Name HA TI-FIT ACETABULAR AND FEMORAL COMPONENT
Applicant
Smith & Nephew Richards, Inc.
1450 Brooks Rd.
Memphis,  TN  38116
Applicant Contact THOMAS L CRAIG
Correspondent
Smith & Nephew Richards, Inc.
1450 Brooks Rd.
Memphis,  TN  38116
Correspondent Contact THOMAS L CRAIG
Regulation Number888.3353
Classification Product Code
MEH  
Date Received06/03/1992
Decision Date 03/17/1994
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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