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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, Porous Uncemented
510(k) Number K951741
Device Name REPLICA TOTAL HIP SYSTEM
Applicant
Osteo-Technology Intl., Inc.
11201 Pepper Rd.
Hunt Valley,  MD  21031
Applicant Contact JOHN A ROBERTS
Correspondent
Osteo-Technology Intl., Inc.
11201 Pepper Rd.
Hunt Valley,  MD  21031
Correspondent Contact JOHN A ROBERTS
Regulation Number888.3358
Classification Product Code
LPH  
Date Received03/31/1995
Decision Date 08/07/1995
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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