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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, Uncemented
510(k) Number K040685
Device Name Z - SERIES MODULAR TOTAL HIP SYSTEM PLASMA COATED
Applicant
Osteoimplant Technology, Inc.
11201 Pepper Rd.
Hunt Valley,  MD  21031
Applicant Contact SAM SON
Correspondent
Osteoimplant Technology, Inc.
11201 Pepper Rd.
Hunt Valley,  MD  21031
Correspondent Contact SAM SON
Regulation Number888.3360
Classification Product Code
LWJ  
Subsequent Product Codes
JDI   KWL   KWY   LZO  
Date Received03/16/2004
Decision Date 01/25/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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