M.U.S.T. Pedicle Screw System - Extension— 510(k) K253940
Substantially EquivalentMedacta International S.A.
FDA 510(k) clearance K253940 for M.U.S.T. Pedicle Screw System - Extension, Substantially Equivalent on 2026-04-28. Applicant: Medacta International S.A.. Device class: 2.
Summary
Medacta International's M.U.S.T. Pedicle Screw System - Extension is filed under product code NKB (Thoracolumbosacral Pedicle Screw System). The record doesn't describe the system beyond its name and that code name.
Class II, 21 CFR 888.3070. Orthopedic is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Medacta filed from Castel San Pietro, Switzerland. The decision came 140 calendar days after FDA received it (December 9, 2025 to April 28, 2026).
Clearance details
- Applicant
- Medacta International S.A.
- Product code
- Product code NKB
- Device class
- Class 2
- Regulation
- 21 CFR 888.3070
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Castel San Pietro, CH
Recent devices under product code NKB
view allMore clearances from Medacta International S.A.
view allAdverse events under product code NKB
product code NKB- Death
- 27
- Injury
- 5,033
- Malfunction
- 4,140
- Total
- 9,200
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.