FDA 510(k)

Salto XT, Salto Talaris

K-Number: K153452 · 2016-08-11

Decision Date2016-08-11

Product CodeHSN

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Salto XT, Salto Talaris is a medical device manufactured by Tornier S.A.S.. It received FDA 510(k) clearance on 2016-08-11 under approval number K153452. The device is classified under product code HSN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Salto XT, Salto Talaris?

Salto XT, Salto Talaris is a medical device that received FDA 510(k) clearance on 2016-08-11. It is manufactured by Tornier S.A.S.. The 510(k) number is K153452.

When was Salto XT, Salto Talaris approved by the FDA?

Salto XT, Salto Talaris received FDA 510(k) clearance on 2016-08-11, under approval number K153452.

What company makes Salto XT, Salto Talaris?

Salto XT, Salto Talaris is manufactured by Tornier S.A.S..

What is the FDA product code for Salto XT, Salto Talaris?

The FDA product code for Salto XT, Salto Talaris is HSN.

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Official Source

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