Cleared Special

CORIN OPTIMOM MODULAR HEAD

K111911 · Corin USA · Orthopedic
Aug 2011
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K111911 is an FDA 510(k) clearance for the CORIN OPTIMOM MODULAR HEAD, a Prosthesis, Hip, Hemi-, Femoral, Metal (Class II — Special Controls, product code KWL), submitted by Corin USA (Tampa, US). The FDA issued a Cleared decision on August 4, 2011, 30 days after receiving the submission on July 5, 2011. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3360.

Submission Details

510(k) Number K111911 FDA.gov
FDA Decision Cleared SESE
Date Received July 05, 2011
Decision Date August 04, 2011
Days to Decision 30 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

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

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