Cleared Traditional

LATITUDE EV? Total Elbow Arthroplasty

K193247 · Tornier, Inc. · Orthopedic
Aug 2020
Decision
254d
Days
Class 2
Risk

About This 510(k) Submission

K193247 is an FDA 510(k) clearance for the LATITUDE EV? Total Elbow Arthroplasty, a Prosthesis, Elbow, Semi-constrained, Cemented (Class II — Special Controls, product code JDB), submitted by Tornier, Inc. (Bloomington, US). The FDA issued a Cleared decision on August 5, 2020, 254 days after receiving the submission on November 25, 2019. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3160.

Submission Details

510(k) Number K193247 FDA.gov
FDA Decision Cleared SESE
Date Received November 25, 2019
Decision Date August 05, 2020
Days to Decision 254 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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