Clearance Summary
ORTHO SELECT BONE PLATES AND SCREW SYSTEM received FDA 510(k) clearance under submission number K091493, sponsored by Ortho Select Implant Technology Gesellschaft. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2010-02-05.
- Submission: K091493
- Applicant / Sponsor: Ortho Select Implant Technology Gesellschaft
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3030
- Decision date: 2010-02-05
Classification & Regulation
This clearance is catalogued under FDA product code HRS and 21 CFR 888.3030, within the Orthopedic review panel as a Class II device.