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Brigit Surgical Device

by Zimmer, Inc.

510(k) K060556

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 NumberK060556 Date31 Jul 2006ClearedStatusActive

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  • Withdrawn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
HAW
Device class
Class II
Regulation
21 CFR Part 882.4560
Advisory committee
Neurology
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 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 Brigit Surgical Device is a computer-controlled, electromechanical, multi-jointed robotic arm classified as a Neurological Stereotaxic Instrument (product code HAW). It is designed to assist surgeons by determining reference alignment axes relative to anatomical landmarks, planning instrument positions, and providing stable, accurate mechanical guidance for orthopedic procedures.

This device is intended for use in operating rooms and has received FDA 510(k) clearance under Traditional review, classified as Class II with Special Controls. It is supplied as a reusable medical instrument and is regulated under the Neurology advisory committee. The device was cleared by the FDA on July 31, 2006, following a review process.

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