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FDA 510(k)

Salto XT, Salto Talaris

K-Number: K153452 · 2016-08-11

ApplicantTornier S.A.S.
Decision Date2016-08-11
Product CodeHSN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Salto XT, Salto Talaris is the device name listed in this FDA 510(k) record. The listed applicant is Tornier S.A.S.. It received FDA 510(k) clearance on 2016-08-11 under 510(k) 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. The listed applicant is Tornier S.A.S.. The 510(k) number is K153452.

When did Salto XT, Salto Talaris receive FDA 510(k) clearance?

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

Who is the listed applicant for Salto XT, Salto Talaris?

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

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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Related Devices (Code: HSN)

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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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