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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, Hemi-, Femoral, Metal
510(k) Number K112470
Device Name 2GC HIP/KNEE MODULAR SPACER
Applicant
Mandell Horwitz Consultants, LLC
2995 Steven Martin Dr.
Fairfax,  VA  22031
Applicant Contact DIANE M HORWITZ
Correspondent
Mandell Horwitz Consultants, LLC
2995 Steven Martin Dr.
Fairfax,  VA  22031
Correspondent Contact DIANE M HORWITZ
Regulation Number888.3360
Classification Product Code
KWL  
Subsequent Product Codes
JWH   KWY   MBB  
Date Received08/26/2011
Decision Date 04/05/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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