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Biomet Access System

by Biomet Spine (Aka Ebi, LLC)

510(k) K132373

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK132373 Date27 Mar 2014ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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
PDQ
Device Class
Class II
Regulation
21 CFR Part 874.1820
Advisory Committee
Ear, Nose, Throat
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 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 Biomet Access System is a neurosurgical nerve locator device used in ear, nose, and throat procedures. It is designed to assist in the localization of nerves during surgical interventions.

The device is supplied as a reusable system and has received FDA 510(k) clearance under K132373. It is classified as a Class II medical device and is intended for use in clinical settings by trained healthcare professionals.

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Questions

AI-generated answers, 23 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 Biomet Access System used for?

    The Biomet Access System is a neurosurgical nerve locator device designed to assist in the localization of nerves during surgical interventions, specifically in ear, nose, and throat procedures. It helps surgeons identify nerve locations to reduce the risk of intraoperative nerve injury.

  • Is the Biomet Access System reusable or single-use?

    The Biomet Access System is supplied as a reusable system, meaning it is designed for multiple uses after appropriate cleaning and sterilization between procedures, as indicated in the device description.

  • What regulatory clearance does the Biomet Access System have?

    The Biomet Access System has received FDA 510(k) clearance under submission number K132373, which was granted on March 27, 2014, following a traditional review process and a determination of substantial equivalence.

  • Who manufactures the Biomet Access System and where are they located?

    The Biomet Access System is manufactured by Biomet Spine, also known as Ebi, LLC, located at 399 Jefferson Rd., Parsippany, NJ 07054, United States, as specified in the device authorization details.