K234048
- 510(k) number
- K234048
- Device name
- M.U.S.T. Pedicle Screw System - Extension
- Applicant
- Medacta International S.A. CH
- Product code
- NKB — Thoracolumbosacral Pedicle Screw System
- Decision date
- 2024-02-13
- Date received
- 2023-12-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
510(k) Summary (official FDA PDF): K234048.pdf
Official FDA record: K234048
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.