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FDA 510(k)

Origin™ TT Stem

K-Number: K243029 · 2025-03-11

ApplicantSignature Orthopaedics Pty, Ltd.
Decision Date2025-03-11
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Origin™ TT Stem is a medical device manufactured by Signature Orthopaedics Pty, Ltd.. It received FDA 510(k) clearance on 2025-03-11 under approval number K243029. 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 Origin™ TT Stem?

Origin™ TT Stem is a medical device that received FDA 510(k) clearance on 2025-03-11. It is manufactured by Signature Orthopaedics Pty, Ltd.. The 510(k) number is K243029.

When was Origin™ TT Stem approved by the FDA?

Origin™ TT Stem received FDA 510(k) clearance on 2025-03-11, under approval number K243029.

What company makes Origin™ TT Stem?

Origin™ TT Stem is manufactured by Signature Orthopaedics Pty, Ltd..

What is the FDA product code for Origin™ TT Stem?

The FDA product code for Origin™ TT Stem 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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