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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 K004032
Device Name PERFECTA AND EXTEND
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 Number888.3358
Classification Product Code
LPH  
Subsequent Product Code
JDI  
Date Received12/28/2000
Decision Date 02/15/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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