Cleared Traditional

ENDO HEAD

K111145 · Medacta International · Orthopedic
Aug 2011
Decision
116d
Days
Class 2
Risk

About This 510(k) Submission

K111145 is an FDA 510(k) clearance for the ENDO HEAD, a Prosthesis, Hip, Hemi-, Femoral, Metal Ball (Class II — Special Controls, product code LZY), submitted by Medacta International (Camarillo, US). The FDA issued a Cleared decision on August 16, 2011, 116 days after receiving the submission on April 22, 2011. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3360.

Submission Details

510(k) Number K111145 FDA.gov
FDA Decision Cleared SESE
Date Received April 22, 2011
Decision Date August 16, 2011
Days to Decision 116 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code LZY — Prosthesis, Hip, Hemi-, Femoral, Metal Ball
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3360

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