Clearance Summary
MAXMORESPINE TOM STICK received FDA 510(k) clearance under submission number K083552, sponsored by Hoogland Spine Products, GmbH. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2009-10-09.
- Submission: K083552
- Applicant / Sponsor: Hoogland Spine Products, GmbH
- Clearance pathway: Abbreviated
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.1100
- Decision date: 2009-10-09
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.