Clearance Summary
TITANIUIM BONE SCREW received FDA 510(k) clearance under submission number K853869, sponsored by George Tiemann & 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 1985-12-09.
- Submission: K853869
- Applicant / Sponsor: George Tiemann & Co.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3040
- Decision date: 1985-12-09
Classification & Regulation
This clearance is catalogued under FDA product code HWC and 21 CFR 888.3040, within the Orthopedic review panel as a Class II device.