Clearance Summary
SPINAL FORAMINOSCOPE received FDA 510(k) clearance under submission number K082841, sponsored by Blazejewski Medi-Tech GmbH. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2009-09-09.
- Submission: K082841
- Applicant / Sponsor: Blazejewski Medi-Tech GmbH
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.1100
- Decision date: 2009-09-09
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.