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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented
510(k) Number K122783
Device Name PLASMAFIT ACETABULAR CUP AND VITELENE INSERT
Applicant
Aesculap Implant System, Inc.
3 773 Corporate Pkwy.
Center Valley,  PA  18034
Applicant Contact JULIE TOM WING
Correspondent
Aesculap Implant System, Inc.
3 773 Corporate Pkwy.
Center Valley,  PA  18034
Correspondent Contact JULIE TOM WING
Regulation Number888.3358
Classification Product Code
OQG  
Subsequent Product Codes
JDI   LPH   LWJ   LZO   OQH  
OQI  
Date Received09/11/2012
Decision Date 10/30/2013
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
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