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FDA 510(k)

T2 Alpha Femur Retrograde Nailing System

K-Number: K250163 · 2025-08-13

ApplicantStryker GmbH
Decision Date2025-08-13
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

T2 Alpha Femur Retrograde Nailing System is a medical device manufactured by Stryker GmbH. It received FDA 510(k) clearance on 2025-08-13 under approval number K250163. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the T2 Alpha Femur Retrograde Nailing System?

T2 Alpha Femur Retrograde Nailing System is a medical device that received FDA 510(k) clearance on 2025-08-13. It is manufactured by Stryker GmbH. The 510(k) number is K250163.

When was T2 Alpha Femur Retrograde Nailing System approved by the FDA?

T2 Alpha Femur Retrograde Nailing System received FDA 510(k) clearance on 2025-08-13, under approval number K250163.

What company makes T2 Alpha Femur Retrograde Nailing System?

T2 Alpha Femur Retrograde Nailing System is manufactured by Stryker GmbH.

What is the FDA product code for T2 Alpha Femur Retrograde Nailing System?

The FDA product code for T2 Alpha Femur Retrograde Nailing System is HSB.

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Other Devices by Stryker GmbH

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Related Devices (Code: HSB)

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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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