Clearance Summary
X-STEN MILD TOOL KIT, MODEL MTK-0001 received FDA 510(k) clearance under submission number K062038, sponsored by X-Sten Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2006-12-19.
- Submission: K062038
- Applicant / Sponsor: X-Sten Corp.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.1100
- Decision date: 2006-12-19
Classification & Regulation
This clearance is catalogued under FDA product code HRX and 21 CFR 888.1100, within the Orthopedic review panel as a Class II device.