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SpineAssist Device

by Mazor Surgical Technologies, Ltd.

510(k) K033413

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 NumberK033413 Date7 Jan 2004ClearedStatusActive

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  • Withdrawn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
FDA applicant
Mazor Surgical Technologies , Ltd.
Device Class
Class II
Regulation
21 CFR Part 882.4560
Advisory Committee
Neurology
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 SpineAssist Device is a robotic guidance system for spine surgery, designed to enhance accuracy during surgical procedures. It is intended for use by spine surgeons to improve precision in spinal operations.

The device is supplied as a single-use system and requires appropriate storage conditions. It has received FDA 510(k) clearance with product code HAW and is substantially equivalent to predicate devices including the original SpineAssist system and the StealthStation System.

Other devices from Mazor Surgical Technologies, Ltd.

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 SpineAssist Device used for?

    The SpineAssist Device is a robotic guidance system designed for spine surgeons to enhance accuracy and precision during spinal surgical procedures.

  • Is the SpineAssist Device single-use or reusable?

    The SpineAssist Device is supplied as a single-use system and requires appropriate storage conditions before use.

  • What regulatory approvals has the SpineAssist Device received?

    The SpineAssist Device has received FDA 510(k) clearance with product code HAW and is substantially equivalent to predicate devices including the original SpineAssist system and the StealthStation System.

  • Who manufactures the SpineAssist Device?

    The SpineAssist Device is manufactured by Mazor Surgical Technologies, Ltd., located in Kfar Saba, Israel.