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HALO ESPRIT

by Itm Corp.

510(k) K920117

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 NumberK920117 Date6 Oct 1992ClearedStatusActive

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  • Withdrawn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
JEC
Device Class
Class II
Regulation
21 CFR Part 888.3040
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

Component, Traction, Invasive is a device used in orthopedic applications for providing traction. It is classified as a Class II medical device under regulation 888.3040.

The device was cleared via the FDA 510(k) pathway with K number K920117, determined to be substantially equivalent. It is supplied by Itm Corp. and is intended for use in orthopedic settings as defined by its regulatory classification.

Questions

AI-generated answers, 25 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 HALO ESPRIT used for?

    The HALO ESPRIT is an invasive traction component used in orthopedic applications to provide mechanical traction, as defined by its classification under regulation 888.3040 for orthopedic devices.

  • How is the HALO ESPRIT supplied and by whom?

    The HALO ESPRIT is supplied by Itm Corp., located at 1000 Burnett Ave., Suite 250, Concord, CA 94520, as indicated in the manufacturer’s address details within the device data.

  • Is the HALO ESPRIT a single-use or reusable device?

    The device data does not specify whether the HALO ESPRIT is single-use or reusable; therefore, no conclusion can be drawn about its reusability from the provided information.

  • What regulatory pathway was used to clear the HALO ESPRIT?

    The HALO ESPRIT was cleared via the FDA 510(k) pathway with K number K920117, determined to be substantially equivalent to a predicate device, as stated in the decision description and clearance type fields.

  • What is the device classification and product code for the HALO ESPRIT?

    The HALO ESPRIT is classified as a Class II medical device with product code JEC, as indicated by the device_class=2 and product_code=JEC fields in the openfda data.