Cleared Traditional

TORNIER ELBOW PROSTHESIS

K050848 · Tornier · Orthopedic
Jul 2005
Decision
101d
Days
Class 2
Risk

About This 510(k) Submission

K050848 is an FDA 510(k) clearance for the TORNIER ELBOW PROSTHESIS, a Prosthesis, Elbow, Semi-constrained, Cemented (Class II — Special Controls, product code JDB), submitted by Tornier (Monbonnot Saint Martin, FR). The FDA issued a Cleared decision on July 14, 2005, 101 days after receiving the submission on April 4, 2005. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3160.

Submission Details

510(k) Number K050848 FDA.gov
FDA Decision Cleared SESE
Date Received April 04, 2005
Decision Date July 14, 2005
Days to Decision 101 days
Submission Type Traditional
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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