Cleared Special

LATITUDE ELBOW PROSTHESIS

K100562 · Tornier, Inc. · Orthopedic
Jun 2010
Decision
120d
Days
Class 2
Risk

About This 510(k) Submission

K100562 is an FDA 510(k) clearance for the LATITUDE ELBOW PROSTHESIS, a Prosthesis, Elbow, Semi-constrained, Cemented (Class II — Special Controls, product code JDB), submitted by Tornier, Inc. (Beverly, US). The FDA issued a Cleared decision on June 29, 2010, 120 days after receiving the submission on March 1, 2010. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3160.

Submission Details

510(k) Number K100562 FDA.gov
FDA Decision Cleared SESE
Date Received March 01, 2010
Decision Date June 29, 2010
Days to Decision 120 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code JDB — Prosthesis, Elbow, Semi-constrained, Cemented
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3160

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