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FDA 510(k)

Cadence Ankle PSI System

K-Number: K243174 · 2024-10-25

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

Device Summary

Cadence 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 K243174. 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 Cadence Ankle PSI System?

Cadence 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 K243174.

When was Cadence Ankle PSI System approved by the FDA?

Cadence Ankle PSI System received FDA 510(k) clearance on 2024-10-25, under approval number K243174.

What company makes Cadence Ankle PSI System?

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

What is the FDA product code for Cadence Ankle PSI System?

The FDA product code for Cadence Ankle PSI System is OYK.

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Other Devices by 3D Systems, Inc.

K151285VSP Cranial System K161841D2P K183489D2P K190044VSP Orthopedics System K231585Vantage PSI System K243173Salto Talaris Ankle PSI System

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Related Devices (Code: OYK)

K193432Vantage PSI System3D Systems K231585Vantage PSI System3D Systems, Inc. K223326Axiom PSR SystemRestor3D K243173Salto Talaris 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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