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FDA 510(k)

T2 Alpha Tibia Nailing System, IMN Screws System

K-Number: K193308 · 2020-02-23

ApplicantStryker Trauma GmbH
Decision Date2020-02-23
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

T2 Alpha Tibia Nailing System, IMN Screws System is a medical device manufactured by Stryker Trauma GmbH. It received FDA 510(k) clearance on 2020-02-23 under approval number K193308. 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 Tibia Nailing System, IMN Screws System?

T2 Alpha Tibia Nailing System, IMN Screws System is a medical device that received FDA 510(k) clearance on 2020-02-23. It is manufactured by Stryker Trauma GmbH. The 510(k) number is K193308.

When was T2 Alpha Tibia Nailing System, IMN Screws System approved by the FDA?

T2 Alpha Tibia Nailing System, IMN Screws System received FDA 510(k) clearance on 2020-02-23, under approval number K193308.

What company makes T2 Alpha Tibia Nailing System, IMN Screws System?

T2 Alpha Tibia Nailing System, IMN Screws System is manufactured by Stryker Trauma GmbH.

What is the FDA product code for T2 Alpha Tibia Nailing System, IMN Screws System?

The FDA product code for T2 Alpha Tibia Nailing System, IMN Screws System is HSB.

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Other Devices by Stryker Trauma GmbH

K170418Stryker SonicPin System K180436T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments System K172774T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments System K191271T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia Nailing System, IMN Screws System, IMN Instruments System K200869Gamma3 System

Related Devices (Code: HSB)

K161264TRIGEN Low Profile Bone ScrewsSmith & Nephew, Inc. K160545GAP ENDO-EXO MEDULLARY SYSTEMPega Medical, Inc. K161254Renovo Life Small Bone IM Nail SystemRenovo Life, LLC K160167DePuy Synthes TFNA Augmentation SystemSynthes (USA) Products, LLC K160325PRECICE Intramedullary Limb Lengthening SystemEllipse Technologies, Inc. K160267PRECICE Trauma Nail SystemEllipse Technologies, Incorporated

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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