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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/ceramic/polymer, cemented or non-porous, uncemented
510(k) Number K090299
Device Name BIOLOX OPTION CERAMIC FEMORAL HEAD AND METHA XL HEADS
Applicant
AESCULAP IMPLANT SYSTEMS
3773 CORPORATE PWKY.
CENTER VALLEY,  PA  18034
Applicant Contact KATHY A RACOSKY
Correspondent
AESCULAP IMPLANT SYSTEMS
3773 CORPORATE PWKY.
CENTER VALLEY,  PA  18034
Correspondent Contact KATHY A RACOSKY
Regulation Number888.3353
Classification Product Code
LZO  
Subsequent Product Codes
KWY   LWJ   MEH  
Date Received02/06/2009
Decision Date 04/24/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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