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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 K921382
Device Name FUTURA TEXTURE-TRAKKED TOTAL HIP STEM
Applicant
Arthronics, Inc.
6685 Quince
Suite 106
Memphis,  TN  38119
Applicant Contact RICARDO J HEROS
Correspondent
Arthronics, Inc.
6685 Quince
Suite 106
Memphis,  TN  38119
Correspondent Contact RICARDO J HEROS
Regulation Number888.3360
Classification Product Code
LWJ  
Subsequent Product Code
JDG  
Date Received03/23/1992
Decision Date 01/07/1994
Decision Substantially Equivalent (SESE)
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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