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Cable-Ease Plate And Cable System

by Intermedics Orthopedics

510(k) K944529

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)SN Traditional NumberK944529 Date17 Feb 1995DecidedStatusActive

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  • Withdrawn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
JDQ
Device Class
Class II
Regulation
21 CFR Part 888.3010
Advisory Committee
Orthopedic
FDA Decision
SN

Overview

AI-generated summary, 26 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 Cable-Ease Plate And Cable System is a device classified as a Cerclage, Fixation device. It is used for orthopedic indications.

The device is supplied by Intermedics Orthopedics and has been cleared by the FDA with a 510(k) clearance, specifically K944529. The device has a product code of JDQ and is classified as a Class II device with special controls.

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Questions

AI-generated answers, 26 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 Cable-Ease Plate And Cable System used for?

    The Cable-Ease Plate And Cable System is used for orthopedic indications, providing fixation and cerclage capabilities.

  • How is the Cable-Ease Plate And Cable System supplied?

    The device is supplied by Intermedics Orthopedics, with a product code of JDQ and classified as a Class II device with special controls.

  • What is the regulatory status of the Cable-Ease Plate And Cable System?

    The device has been cleared by the FDA with a 510(k) clearance, specifically K944529, indicating substantial equivalence for some indications.