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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 K092143
Device Name EXCIA TOTAL HIP SYSTEM M AN ML FEMORAL STEM
Applicant
Aesculap Implant Systems, Inc.
3773 Corporate Pwky.
Center Valley,  PA  18034
Applicant Contact KATHY A RACOSKY
Correspondent
Aesculap Implant Systems, Inc.
3773 Corporate Pwky.
Center Valley,  PA  18034
Correspondent Contact KATHY A RACOSKY
Regulation Number888.3353
Classification Product Code
MEH  
Subsequent Product Codes
KWY   LZO  
Date Received07/15/2009
Decision Date 09/22/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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