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FDA 510(k)

LATITUDE EV™ Total Elbow Arthroplasty

K-Number: K193247 · 2020-08-05

ApplicantTornier, Inc.
Decision Date2020-08-05
Product CodeJDB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

LATITUDE EV™ Total Elbow Arthroplasty is the device name listed in this FDA 510(k) record. The listed applicant is Tornier, Inc.. It received FDA 510(k) clearance on 2020-08-05 under 510(k) number K193247. 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 2020-08-05. The listed applicant is Tornier, Inc.. The 510(k) number is K193247.

When did LATITUDE EV™ Total Elbow Arthroplasty receive FDA 510(k) clearance?

LATITUDE EV™ Total Elbow Arthroplasty received FDA 510(k) clearance on 2020-08-05, under 510(k) number K193247.

Who is the listed applicant for LATITUDE EV™ Total Elbow Arthroplasty?

The FDA 510(k) record lists Tornier, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Tornier, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260721Tornier Perform Advanced GlenoidK252788Tornier Perform™ Reversed Monopost Glenoid (Perform Mono)K251686Tornier Humeral Reconstruction System Max (Tornier HRS Max)K230352Tornier Humeral Nail and Tornier Long Humeral NailK220914Tornier Perform Humeral System – FractureK220418Tornier Perform Humeral System – Stemless

View all 19 devices →

Related Devices (Code: JDB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K222807TEMA Elbow system - Line extensionLima Corporate S.P.A.K182461LATITUDE EV Total Elbow ArthroplastyTornier, Inc.K171010Latitude EV Total Elbow ArthroplastyTornier, Inc.

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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