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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 K112682
Device Name METHA HIP SYSTEM
Original Applicant
AESCULAP IMPLANT SYSTEMS, LLC
3773 corporate parkway
center valley,  PA  18034
Original Contact kathy a racosky
Regulation Number888.3353
Classification Product Code
LZO  
Subsequent Product Codes
LWJ   MEH  
Date Received09/15/2011
Decision Date 03/19/2012
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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