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FDA 510(k)

Signature Ceramic Femoral Head

K-Number: K190704 · 2019-08-28

ApplicantSignature Orthopaedics Pty, Ltd.
Decision Date2019-08-28
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Signature Ceramic Femoral Head is a medical device manufactured by Signature Orthopaedics Pty, Ltd.. It received FDA 510(k) clearance on 2019-08-28 under approval number K190704. 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 Signature Ceramic Femoral Head?

Signature Ceramic Femoral Head is a medical device that received FDA 510(k) clearance on 2019-08-28. It is manufactured by Signature Orthopaedics Pty, Ltd.. The 510(k) number is K190704.

When was Signature Ceramic Femoral Head approved by the FDA?

Signature Ceramic Femoral Head received FDA 510(k) clearance on 2019-08-28, under approval number K190704.

What company makes Signature Ceramic Femoral Head?

Signature Ceramic Femoral Head is manufactured by Signature Orthopaedics Pty, Ltd..

What is the FDA product code for Signature Ceramic Femoral Head?

The FDA product code for Signature Ceramic Femoral Head is 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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