Cleared Traditional

Latitude EV Total Elbow Arthroplasty

K171010 · Tornier, Inc. · Orthopedic
Aug 2017
Decision
149d
Days
Class 2
Risk

About This 510(k) Submission

K171010 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 31, 2017, 149 days after receiving the submission on April 4, 2017. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3160.

Submission Details

510(k) Number K171010 FDA.gov
FDA Decision Cleared SESE
Date Received April 04, 2017
Decision Date August 31, 2017
Days to Decision 149 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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