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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 K021346
Device Name STEM HIP REPLACEMENT SYSTEM, MODEL PHA002XX
Applicant
WRIGHT MEDICAL TECHNOLOGY, INC.
5677 AIRLINE RD.
arlington,  TN  38002
Applicant Contact roger d brown
Correspondent
WRIGHT MEDICAL TECHNOLOGY, INC.
5677 AIRLINE RD.
arlington,  TN  38002
Correspondent Contact roger d brown
Regulation Number888.3358
Classification Product Code
LPH  
Date Received04/29/2002
Decision Date 07/02/2002
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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