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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 K101475
Device Name COMPRESS ANTI-ROTATION SPINDLES
Applicant
Biomet Manufacturing Corp
56 E. Bell Dr.,
P.O. Box 587
Warsaw,  IN  46581
Applicant Contact PATRICIA SANDBORN BERES
Correspondent
Biomet Manufacturing Corp
56 E. Bell Dr.,
P.O. Box 587
Warsaw,  IN  46581
Correspondent Contact PATRICIA SANDBORN BERES
Regulation Number888.3330
Classification Product Code
KWA  
Subsequent Product Codes
JDI   JDL   KRO   KWY   KWZ  
LPH   LZO   MEH  
Date Received05/28/2010
Decision Date 06/18/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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