Clearance Summary
T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia Nailing System, IMN Screws System, IMN Instruments System received FDA 510(k) clearance under submission number K191271, sponsored by Stryker Trauma GmbH. The device was reviewed via the Special premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2019-06-11.
- Submission: K191271
- Applicant / Sponsor: Stryker Trauma GmbH
- Clearance pathway: Special
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3020
- Decision date: 2019-06-11
Classification & Regulation
This clearance is catalogued under FDA product code HSB and 21 CFR 888.3020, within the Orthopedic review panel as a Class II device.