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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 K003016
Device Name PRO-FEMUR R
Applicant
WRIGHT MEDICAL TECHNOLOGY, INC.
5677 AIRLINE RD.
ARLINGTON,  TN  38002
Applicant Contact EHAB M ESMAIL
Correspondent
WRIGHT MEDICAL TECHNOLOGY, INC.
5677 AIRLINE RD.
ARLINGTON,  TN  38002
Correspondent Contact EHAB M ESMAIL
Regulation Number888.3360
Classification Product Code
LWJ  
Date Received09/27/2000
Decision Date 12/13/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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