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FDA 510(k)

Latitude EV Total Elbow Arthroplasty

K-Number: K171010 · 2017-08-31

ApplicantTornier, Inc.
Decision Date2017-08-31
Product CodeJDB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Latitude EV Total Elbow Arthroplasty is a medical device manufactured by Tornier, Inc.. It received FDA 510(k) clearance on 2017-08-31 under approval number K171010. The device is classified under product code JDB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Latitude EV Total Elbow Arthroplasty?

Latitude EV Total Elbow Arthroplasty is a medical device that received FDA 510(k) clearance on 2017-08-31. It is manufactured by Tornier, Inc.. The 510(k) number is K171010.

When was Latitude EV Total Elbow Arthroplasty approved by the FDA?

Latitude EV Total Elbow Arthroplasty received FDA 510(k) clearance on 2017-08-31, under approval number K171010.

What company makes Latitude EV Total Elbow Arthroplasty?

Latitude EV Total Elbow Arthroplasty is manufactured by Tornier, Inc..

What is the FDA product code for Latitude EV Total Elbow Arthroplasty?

The FDA product code for Latitude EV Total Elbow Arthroplasty is JDB.

Related Clinical Trials

NCT07191067 Pivotal Study on the NOVABLOC System for Patients Undergoing Primary Total Knee Arthroplasty RECRUITING NCT07613203 Forced-Air Warming for Preventing Perioperative Hypothermia During Total Knee Arthroplasty COMPLETED NCT07615972 Efficacy of a Roller Device Facilitating Self-massage in the Treatment of Chronic Lateral Epicondylitis NOT_YET_RECRUITING NCT06019832 Analysis of Varus Collapse in Obese Patients With Stem and Non-Stem Tibial Components Following Primary Total Knee Arthroplasty ACTIVE_NOT_RECRUITING NCT05543941 Evaluating XPERIENCE™ Advanced Surgical Irrigation RECRUITING NCT07611526 Investigation of the Individual Fatigue Response During Blood Flow Restriction Training NOT_YET_RECRUITING

Related PubMed Literature

PMID: 40025985 Patient-reported outcome measures offer little additional value two years after arthroplasty : a systematic review and meta-analysis. The bone & joint journal (2025)

Other Devices by Tornier, Inc.

K161742Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed Glenoid K160975Aequalis PerFORM+ Shoulder System K182461LATITUDE EV Total Elbow Arthroplasty K181587ORTHOLOC SPS Shoulder Plating System K181420Aequalis Flex Revive Shoulder System K191711ORTHOLOC™ SPS Shoulder Plating System

View all 18 devices →

Related Devices (Code: JDB)

K182461LATITUDE EV Total Elbow ArthroplastyTornier, Inc. K193247LATITUDE EV™ Total Elbow ArthroplastyTornier, Inc. K222807TEMA Elbow system - Line extensionLima Corporate S.P.A.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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