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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, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
510(k) Number K071916
Device Name METHA HIP SYSTEM
Applicant
AESCULAP IMPLANT SYSTEMS, INC.
3773 CORPORATE PKWY.
CENTER VALLEY,  PA  18034
Applicant Contact KATHY A RACOSKY
Correspondent
AESCULAP IMPLANT SYSTEMS, INC.
3773 CORPORATE PKWY.
CENTER VALLEY,  PA  18034
Correspondent Contact KATHY A RACOSKY
Regulation Number888.3353
Classification Product Code
MEH  
Subsequent Product Codes
KWY   LWJ  
Date Received07/11/2007
Decision Date 06/02/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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