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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 uncemented acetabular component)
510(k) Number K043099
Device Name LINEAGE HA ACETABULAR SHELLS
Applicant
WRIGHT MEDICAL TECHNOLOGY, INC.
5677 AIRLINE RD.
arlington,  TN  38002
Applicant Contact jeanine h redden
Correspondent
WRIGHT MEDICAL TECHNOLOGY, INC.
5677 AIRLINE RD.
arlington,  TN  38002
Correspondent Contact jeanine h redden
  No 510(k) holder with active listings identified
Current 510(k) Holder
No 510(k) holder with active listings identified
Regulation Number888.3330
Classification Product Code
KWA  
Subsequent Product Codes
LPH   MEH  
Date Received11/09/2004
Decision Date 09/29/2005
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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