Clearance Summary
Mini-OSTEO Pedicle Fixation System received FDA 510(k) clearance under submission number K231443, sponsored by Osteomed Indústria E Comércio DE Implantes Ltda. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2023-11-21.
- Submission: K231443
- Applicant / Sponsor: Osteomed Indústria E Comércio DE Implantes Ltda
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3070
- Decision date: 2023-11-21
Classification & Regulation
This clearance is catalogued under FDA product code NKB and 21 CFR 888.3070, within the Orthopedic review panel as a Class II device.