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FDA 510(k)

Tornier Humeral Nail and Tornier Long Humeral Nail

K-Number: K230352 · 2023-10-31

ApplicantTornier, Inc.
Decision Date2023-10-31
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Tornier Humeral Nail and Tornier Long Humeral Nail is a medical device manufactured by Tornier, Inc.. It received FDA 510(k) clearance on 2023-10-31 under approval number K230352. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Tornier Humeral Nail and Tornier Long Humeral Nail?

Tornier Humeral Nail and Tornier Long Humeral Nail is a medical device that received FDA 510(k) clearance on 2023-10-31. It is manufactured by Tornier, Inc.. The 510(k) number is K230352.

When was Tornier Humeral Nail and Tornier Long Humeral Nail approved by the FDA?

Tornier Humeral Nail and Tornier Long Humeral Nail received FDA 510(k) clearance on 2023-10-31, under approval number K230352.

What company makes Tornier Humeral Nail and Tornier Long Humeral Nail?

Tornier Humeral Nail and Tornier Long Humeral Nail is manufactured by Tornier, Inc..

What is the FDA product code for Tornier Humeral Nail and Tornier Long Humeral Nail?

The FDA product code for Tornier Humeral Nail and Tornier Long Humeral Nail is HSB.

Related Clinical Trials

NCT05500066 Tornier HRS (Humeral Reconstruction System) Study (REVIVE) ENROLLING_BY_INVITATION

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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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