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FDA 510(k)

LATITUDE ELBOW PROTHESIS

K-Number: K070787 · 2007-08-24

ApplicantTornier
Decision Date2007-08-24
Product CodeJDB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

LATITUDE ELBOW PROTHESIS is the device name listed in this FDA 510(k) record. The listed applicant is Tornier. It received FDA 510(k) clearance on 2007-08-24 under 510(k) number K070787. 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 ELBOW PROTHESIS?

LATITUDE ELBOW PROTHESIS is a medical device that received FDA 510(k) clearance on 2007-08-24. The listed applicant is Tornier. The 510(k) number is K070787.

When did LATITUDE ELBOW PROTHESIS receive FDA 510(k) clearance?

LATITUDE ELBOW PROTHESIS received FDA 510(k) clearance on 2007-08-24, under 510(k) number K070787.

Who is the listed applicant for LATITUDE ELBOW PROTHESIS?

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

What is the FDA product code for LATITUDE ELBOW PROTHESIS?

The FDA product code for LATITUDE ELBOW PROTHESIS is JDB.

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Related Devices (Code: JDB)

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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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