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Ace External Bone Clamp Part #S11

by Ace Orthopedic Manufacturing Co.

510(k) K791466

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 NumberK791466 Date16 Aug 1979ClearedStatusActive

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  • Withdrawn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, 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 Ace External Bone Clamp Part #S11 is an orthopedic device, classified as a component, traction, invasive device. It is used in orthopedic applications.

The device is supplied as a single unit, with a product code of JEC and a regulation number of 888.3040. It has been granted FDA 510K clearance, with a decision description of Substantially Equivalent, and is listed with a k number of K791466.

Other devices from Ace Orthopedic Manufacturing Co.

See all devices from Ace Orthopedic Manufacturing Co. →

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 Ace External Bone Clamp Part #S11 used for?

    The Ace External Bone Clamp Part #S11 is used in orthopedic applications, specifically as a component, traction, invasive device.

  • Is the Ace External Bone Clamp Part #S11 supplied sterile?

    The device data does not specify if the Ace External Bone Clamp Part #S11 is supplied sterile, but it is supplied as a single unit.

  • What is the regulatory status of the Ace External Bone Clamp Part #S11?

    The Ace External Bone Clamp Part #S11 has been granted FDA 510K clearance, with a decision description of Substantially Equivalent, and is listed with a k number of K791466.

  • What is the product code of the Ace External Bone Clamp Part #S11?

    The product code of the Ace External Bone Clamp Part #S11 is JEC, with a regulation number of 888.3040.