100 - Consensus Orthopedics

2. 510(k) SUMMARYP asye I of 3 Sponsor Name: Consensus Orthopedics , Windfield Way, Suite 100El Dorado Hills, CA 95762510(k) Contact: Matthew M. Hull, RACP hone: (916) 355-7156/ Fax: (916) Prepared: 14 August, 2012 Trade Name: TaperSet'F4 H-ip system SmalI StemsCommon Name: Porous-coated hip prosthesis for cenientless useClassification Name: Class HI deviceHip joint metallpolymer/metal semi-constrained porous-coateduncemented prosthesis: 21 CFR , Product Code joint metal/ceramnic/pa lymer semi-constrained cemented ornonporous uncernented prosthesis: 21 CER , ProductCode joint femoral (hemi-hip) metallic cemented or uncementedprosthesis: 21 CFR , Product Code joint femoral (hemi-hip) metal/polymer cemented oruncemented prosthesis: 21 CFR , Product Code Description.

Taperloc Complete Hip System extension. The subject Consensus stemns are still compatible with previously cleared Co~r heads, zirconia and Biolox delta ceramic heads, unipolar heads,

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  System, Complete, Taperloc, Taperloc complete hip system

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