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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 the device name listed in this FDA 510(k) record. The listed applicant is Stryker GmbH. It received FDA 510(k) clearance on 2025-08-13 under 510(k) 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. The listed applicant is Stryker GmbH. The 510(k) number is K250163.

When did T2 Alpha Femur Retrograde Nailing System receive FDA 510(k) clearance?

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

Who is the listed applicant for T2 Alpha Femur Retrograde Nailing System?

The FDA 510(k) record lists Stryker GmbH as the applicant. This does not by itself establish the device manufacturer.

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.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT04015128A Post-Market Clinical Evaluation of the Treatment of Femur Fractures With the Femoral Nail GTCOMPLETEDNCT04015154A Post-Market Clinical Evaluation of the Treatment of Femur Fractures With the Femoral Nail PFCOMPLETED

Other records listing Stryker GmbH as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261481Pangea Femur Reconstruction SystemK253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemK253202Hoffmann LRF SystemK251400T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing SystemK242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea Tibia Plating SystemK233919VariAx 2 Distal Radius System

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Related Devices (Code: HSB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261481Pangea Femur Reconstruction SystemStryker GmbHK261651Precice™ Max System and Precice™ Ankle Salvage SystemNuVasive Specialized OrthopedicsK253080AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)Suzhou and Science & Technology Development Corp.K253155Fule Metallic Lockable Intramedullary Nail SystemsBeijing Fule Science & Technology Development Co., Ltd.K253046HERA Interlocking Intramedullary Nailing SystemZheJiang Decans Medical Devices Co., Ltd.K260146FITBONE® TRANSPORT AND LENGTHENING SYSTEMOrthofix Srl

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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