Clearance Summary
Pedimax II - Pedicular Screw Spinal System received FDA 510(k) clearance under submission number K180626, sponsored by Gm Dos Reis Industria E Comerico 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 2019-02-01.
- Submission: K180626
- Applicant / Sponsor: Gm Dos Reis Industria E Comerico Ltda.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3070
- Decision date: 2019-02-01
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.