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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 K070221
Device Name FMP METAL/METAL ACETABULAR INSERT, 499-28,449-34, 499-38
Applicant
ENCORE MEDICAL, L.P.
9800 METRIC BLVD.
AUSTIN,  TX  78758
Applicant Contact TEFFANY HUTTO
Correspondent
ENCORE MEDICAL, L.P.
9800 METRIC BLVD.
AUSTIN,  TX  78758
Correspondent Contact TEFFANY HUTTO
Regulation Number888.3330
Classification Product Code
KWA  
Subsequent Product Codes
JDI   KWI   KWL   KWZ   LPH  
LWJ   LZO  
Date Received01/24/2007
Decision Date 04/04/2007
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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