M.U.S.T. MINI Posterior Cervical Screws System Extension— 510(k) K220570

Clearance details

Applicant

Medacta International S.A.

Product code

Code NKG

Device class

Class 2

Regulation

21 CFR 888.3075

Advisory panel

Orthopedic

Date received

2022-02-28

Decision date

2022-04-26

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Castel San Pietro (Ch), CH

• K253195 — TAURUS Posterior Occipital-Cervico-Thoracic Spinal Systems2026-06-02
• K254045 — CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw System2026-03-16
• K254165 — Infinity OCT System2026-01-21
• K252327 — CMORE® CT System; CMORE® CT System Navigated Instruments2025-11-12
• K253129 — Infinity OCT System2025-10-24

• K253630 — Mpact 3D Metal Foam2026-08-28
• K254202 — MectaLIF 3D Metal Anterior2026-05-05
• K253940 — M.U.S.T. Pedicle Screw System - Extension2026-04-28
• K253328 — GMK 3D Metal Tibial Tray Extension2026-02-26
• K250644 — MSS - Monobloc stem2026-02-03

Death

15

Injury

1,090

Malfunction

529

Total

1,634

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →