Clearance Summary
SKY BONE EXPANDER SYSTEM received FDA 510(k) clearance under submission number K034037, 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 2004-01-28.
- Submission: K034037
- Applicant / Sponsor: Disc-O-Tech Medical Technologies, Ltd.
- Clearance pathway: Special
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.1100
- Decision date: 2004-01-28
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.