Clearance Summary
B-TWIN BONE EXPANDER SYSTEM (B-TWIN BE SYSTEM) received FDA 510(k) clearance under submission number K032358, sponsored by Disc-O-Tech Medical Technologies, Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2003-12-17.
- Submission: K032358
- Applicant / Sponsor: Disc-O-Tech Medical Technologies, Ltd.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.1100
- Decision date: 2003-12-17
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.