Clearance Summary
SONGER TITANIUM SPINE-L-ROD received FDA 510(k) clearance under submission number K854313, sponsored by Ortho-Engineering Products Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 1985-11-15.
- Submission: K854313
- Applicant / Sponsor: Ortho-Engineering Products Co.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3050
- Decision date: 1985-11-15
Classification & Regulation
This clearance is catalogued under FDA product code KWP and 21 CFR 888.3050, within the Orthopedic review panel as a Class II device.