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EBI Acumen Surgical Navigation System

by Ebi, L.P. 510(k)

Active United States

510(k) K031732

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK031732 Date15 Oct 2003ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

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 EBI Acumen Surgical Navigation System is a Class 2 Neurology device (product code HAW) designed for stereotactic surgical navigation. It provides real-time imaging and spatial mapping to assist surgeons in accurately locating anatomical structures during open or percutaneous orthopedic procedures, particularly in spine and trauma surgeries.

This system is intended for use in operating rooms where precise anatomical referencing is required. Supplied as a reusable medical device, it has received FDA 510(k) clearance under the Traditional pathway after a 133-day review by the Neurology Advisory Committee. No specific sterility or MRI safety information is provided in the available data.

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