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FDA 510(k)

Fusion Taper System

K-Number: K201047 · 2021-04-16

ApplicantSignature Orthopaedics Pty, Ltd.
Decision Date2021-04-16
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Fusion Taper System is a medical device manufactured by Signature Orthopaedics Pty, Ltd.. It received FDA 510(k) clearance on 2021-04-16 under approval number K201047. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Fusion Taper System?

Fusion Taper System is a medical device that received FDA 510(k) clearance on 2021-04-16. It is manufactured by Signature Orthopaedics Pty, Ltd.. The 510(k) number is K201047.

When was Fusion Taper System approved by the FDA?

Fusion Taper System received FDA 510(k) clearance on 2021-04-16, under approval number K201047.

What company makes Fusion Taper System?

Fusion Taper System is manufactured by Signature Orthopaedics Pty, Ltd..

What is the FDA product code for Fusion Taper System?

The FDA product code for Fusion Taper System is LZO.

Related Clinical Trials

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Related Devices (Code: LZO)

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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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