Clearance Summary
SYSTEM TEN, MODEL 100 SURGERY SYST/ORTHOPAEDIC USE received FDA 510(k) clearance under submission number K905451, sponsored by Advanced Osseous Technologies. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 1991-03-05.
- Submission: K905451
- Applicant / Sponsor: Advanced Osseous Technologies
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.4580
- Decision date: 1991-03-05
Classification & Regulation
This clearance is catalogued under FDA product code JDX and 21 CFR 888.4580, within the Orthopedic review panel as a Class II device.