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Monotube Tube-to-Tube Clamp

by Howmedica Corp.

510(k) K954667

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 NumberK954667 Date11 Jan 1996ClearedStatusActive

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  • Withdrawn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, 22 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 Monotube Tube-to-Tube Clamp is a component used in orthopedic applications as part of traction systems. It is designed to connect tubes in invasive procedures, providing a secure attachment point for medical devices.

This device is supplied as a single-use or reusable component, depending on the specific application. It is manufactured by Howmedica Corp. and has FDA 510(k) clearance under product code JEC with regulation number 888.3040. The device is available in various sizes and models as specified by the manufacturer.

Other devices from Howmedica Corp.

See all devices from Howmedica Corp. →

Questions

AI-generated answers, 22 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 Monotube Tube-to-Tube Clamp used for?

    The Monotube Tube-to-Tube Clamp is a component designed for orthopedic applications as part of traction systems. It provides a secure attachment point for medical devices by connecting tubes during invasive procedures.

  • Is the Monotube Tube-to-Tube Clamp single-use or reusable?

    The Monotube Tube-to-Tube Clamp can be supplied as either a single-use or reusable component, depending on the specific application requirements and the manufacturer's specifications.

  • What sizes and models are available for the Monotube Tube-to-Tube Clamp?

    The Monotube Tube-to-Tube Clamp is available in various sizes and models as specified by the manufacturer, Howmedica Corp., to accommodate different orthopedic applications and procedural needs.

  • What regulatory clearance does the Monotube Tube-to-Tube Clamp have?

    The Monotube Tube-to-Tube Clamp has FDA 510(k) clearance under product code JEC with regulation number 888.3040. It was determined to be substantially equivalent to predicate devices for orthopedic applications.