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510(k) K112470

2GC HIP/KNEE MODULAR SPACER by Mandell Horwitz Consultants, LLC — Product Code KWL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 5, 2012
Date Received
August 26, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Hemi-, Femoral, Metal
Device Class
Class II
Regulation Number
888.3360
Review Panel
OR
Submission Type

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