Michelangelo Bunion System - MABS, Model: MA6000

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

510(k) Number

K091763 ↗

FDA Product Code

HTN

Device Class

Class II

Regulation

21 CFR Part 888.3030

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

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• What is the Michelangelo Bunion System MABS used for?

  The Michelangelo Bunion System MABS, Model MA6000 is an orthopedic device specifically designed for bunion correction procedures. It is a specialized surgical instrument system used in orthopedic applications to address bunions.

• How is the Michelangelo Bunion System supplied?

  The Michelangelo Bunion System MABS is supplied by Instratek, Inc. The device is provided as a complete surgical instrument system for use in bunion correction procedures.

• What is the regulatory status of the Michelangelo Bunion System?

  The Michelangelo Bunion System MABS has received FDA 510(k) clearance with the K number K091763. It is classified under product code HTN and was reviewed by the Orthopedic advisory committee.

• Is the Michelangelo Bunion System reusable or single-use?

  The device data does not specify whether the Michelangelo Bunion System is reusable or single-use. This information would be detailed in the product's instructions for use provided by the manufacturer.