K260362
- 510(k) number
- K260362
- Device name
- QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration)
- Applicant
- MANTIZ Co., Ltd. KR
- Product code
- NKB — Thoracolumbosacral Pedicle Screw System
- Decision date
- 2026-07-24
- Date received
- 2026-02-04
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
510(k) Summary (official FDA PDF): K260362.pdf
Official FDA record: K260362
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.