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FDA 510(k)

Salto Talaris Ankle PSI System

K-Number: K243173 · 2024-10-25

Applicant3D Systems, Inc.
Decision Date2024-10-25
Product CodeOYK
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Salto Talaris Ankle PSI System is a medical device manufactured by 3D Systems, Inc.. It received FDA 510(k) clearance on 2024-10-25 under approval number K243173. The device is classified under product code OYK. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Salto Talaris Ankle PSI System?

Salto Talaris Ankle PSI System is a medical device that received FDA 510(k) clearance on 2024-10-25. It is manufactured by 3D Systems, Inc.. The 510(k) number is K243173.

When was Salto Talaris Ankle PSI System approved by the FDA?

Salto Talaris Ankle PSI System received FDA 510(k) clearance on 2024-10-25, under approval number K243173.

What company makes Salto Talaris Ankle PSI System?

Salto Talaris Ankle PSI System is manufactured by 3D Systems, Inc..

What is the FDA product code for Salto Talaris Ankle PSI System?

The FDA product code for Salto Talaris Ankle PSI System is OYK.

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Other Devices by 3D Systems, Inc.

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Related Devices (Code: OYK)

K193432Vantage PSI System3D Systems K231585Vantage PSI System3D Systems, Inc. K223326Axiom PSR SystemRestor3D K243174Cadence Ankle PSI System3D Systems, Inc. K241148Salto Talaris Ankle PSI System3D Systems, Inc. K241326Cadence Ankle PSI System3D Systems, 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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