Clearance Summary
BONUS-ORTHOPEDIC BONE SCREW FIXATION SYSTEM received FDA 510(k) clearance under submission number K011390, sponsored by Disc-O-Tech Medical Technologies, Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2001-06-06.
- Submission: K011390
- Applicant / Sponsor: Disc-O-Tech Medical Technologies, Ltd.
- Clearance pathway: Special
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3040
- Decision date: 2001-06-06
Classification & Regulation
This clearance is catalogued under FDA product code MBI and 21 CFR 888.3040, within the Orthopedic review panel as a Class II device.