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M.U.S.T. MINI Posterior Cervical Screws System Extension

by Medacta International S.A.

510(k) K220570

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK220570 Date26 Apr 2022ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
NKG
Device Class
Class II
Regulation
21 CFR Part 888.3075
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The M.U.S.T. MINI Posterior Cervical Screws System Extension is a device intended for fixation of the occipito-cervico-thoracic spine. It is a comprehensive solution that includes a variety of screws, hooks, rods, and connectors to allow surgeons to tailor the construct to specific patient anatomy and pathology.

The system is supplied as part of a spinal fixation and stabilization construct. It is used in surgical procedures involving pedicle or lateral mass preparation, with components such as polyaxial screws. The device received FDA 510(k) clearance under K220570 and is classified under product code NKG with advisory committee designation OR (Orthopedic).

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Questions

AI-generated answers, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the M.U.S.T. MINI Posterior Cervical Screws System Extension used for?

    The M.U.S.T. MINI Posterior Cervical Screws System Extension is intended for fixation of the occipito-cervico-thoracic spine, allowing surgeons to tailor spinal stabilization constructs using screws, hooks, rods, and connectors based on patient anatomy and pathology.

  • How is the M.U.S.T. MINI Posterior Cervical Screws System Extension supplied?

    The system is supplied as part of a spinal fixation and stabilization construct, including components such as polyaxial screws, hooks, rods, and connectors to support surgical procedures involving pedicle or lateral mass preparation.

  • What regulatory pathway was used for the M.U.S.T. MINI Posterior Cervical Screws System Extension?

    The device received FDA 510(k) clearance under K220570, indicating it was found substantially equivalent to a legally marketed predicate device through the traditional 510(k) review process.