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External Fixation System

by Howmedica Corp.

510(k) K802722

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 NumberK802722 Date19 Nov 1980ClearedStatusActive

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  • Withdrawn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, 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.

An external fixation system is a component, traction, invasive device used in orthopedic applications. It is classified as a Class II medical device.

The system was cleared via the FDA 510(k) pathway under K802722 with a traditional clearance decision. It is manufactured by Howmedica Corp. and is intended for use in orthopedic settings as defined by its product code JEC and regulation number 888.3040.

Other devices from Howmedica Corp.

See all devices from Howmedica Corp. →

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 EXTERNAL FIXATION SYSTEM used for?

    The EXTERNAL FIXATION SYSTEM is an orthopedic component traction invasive device intended for use in orthopedic applications, as defined by its product code JEC and regulation number 888.3040, to stabilize fractures or correct deformities externally.

  • How was the EXTERNAL FIXATION SYSTEM cleared for market?

    The device was cleared via the FDA 510(k) pathway under submission K802722 with a traditional clearance decision, determined to be substantially equivalent to a predicate device, as indicated by the decision code SESE and decision description Substantially Equivalent.

  • Who manufactures the EXTERNAL FIXATION SYSTEM and where is it located?

    The EXTERNAL FIXATION SYSTEM is manufactured by Howmedica Corp., located at 803 N. Front St. Suite 3, Mchenry, IL 60050, United States, as specified in the device’s authorization and registration details.