Cleared Special

LATITUDE ELBOW PROTHESIS

K070787 · Tornier · Orthopedic
Aug 2007
Decision
155d
Days
Class 2
Risk

About This 510(k) Submission

K070787 is an FDA 510(k) clearance for the LATITUDE ELBOW PROTHESIS, a Prosthesis, Elbow, Semi-constrained, Cemented (Class II — Special Controls, product code JDB), submitted by Tornier (Saint-Ismier Cedex, FR). The FDA issued a Cleared decision on August 24, 2007, 155 days after receiving the submission on March 22, 2007. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3160.

Submission Details

510(k) Number K070787 FDA.gov
FDA Decision Cleared SESE
Date Received March 22, 2007
Decision Date August 24, 2007
Days to Decision 155 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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