Clearance Summary
T2 Tibial Nailing System, T2 Femoral Nail System, T2 Supracondylar Nail System, T2 Recon Nail System, T2 Greater Trochanter Nail (GTN),T2 Ankle Arthrodesis Nail,T2 Arthrodesis Nail System received FDA 510(k) clearance under submission number K200880, sponsored by Stryker GmbH. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2020-07-01.
- Submission: K200880
- Applicant / Sponsor: Stryker GmbH
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3020
- Decision date: 2020-07-01
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.