Cleared Traditional

LATITUDE EV Total Elbow Arthroplasty

K182461 · Tornier, Inc. · Orthopedic
Dec 2018
Decision
108d
Days
Class 2
Risk

About This 510(k) Submission

K182461 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 December 27, 2018, 108 days after receiving the submission on September 10, 2018. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3160.

Submission Details

510(k) Number K182461 FDA.gov
FDA Decision Cleared SESE
Date Received September 10, 2018
Decision Date December 27, 2018
Days to Decision 108 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

Similar Devices — JDB Prosthesis, Elbow, Semi-constrained, Cemented

All 26
TEMA Elbow system - Line extension
K222807 · Lima Corporate S.P.A. · Oct 2022
LATITUDE EV? Total Elbow Arthroplasty
K193247 · Tornier, Inc. · Aug 2020
Latitude EV Total Elbow Arthroplasty
K171010 · Tornier, Inc. · Aug 2017
RHEAD RADIAL HEAD EXTENDED STEMS
K102180 · Small Bone Innovations, Inc. · Dec 2010
LATITUDE ELBOW PROSTHESIS
K100562 · Tornier, Inc. · Jun 2010
LATITUDE ELBOW PROTHESIS
K070787 · Tornier · Aug 2007