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Eidosmed, Model EDG4.0

by Eidosmed, LLC

510(k) K091992

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 NumberK091992 Date9 Dec 2009ClearedStatusActive

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  • Withdrawn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
OOL
Device Class
Class II
Regulation
21 CFR Part 888.3030
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 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 Eidosmed, Model Edg4.0 is an Electronic Depth Gauge, a device used to measure the depth of a passageway in a bone or other tissue. It is used to enable the insertion of properly sized screws and implants. The device is designed for surgical use and measures the depth of bone or tissue passageways.

The Eidosmed, Model Edg4.0 is supplied as a disposable device and is intended for single-use. It is classified as a Class 2 device with a regulation number of 888.3030 and is used in the orthopedic medical specialty. The device has been cleared by the FDA with a Traditional clearance type and is assigned the product code OOL.

Questions

AI-generated answers, 21 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 Eidosmed Edg4.0 used for?

    The Eidosmed Edg4.0 is used to measure the depth of a passageway in a bone or other tissue, enabling the insertion of properly sized screws and implants in orthopedic surgery.

  • Is the Eidosmed Edg4.0 reusable?

    No, the Eidosmed Edg4.0 is intended for single-use and is supplied as a disposable device.

  • What medical specialty is the Eidosmed Edg4.0 used in?

    The Eidosmed Edg4.0 is used in the orthopedic medical specialty.