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Coonrad III Total Elbow

by Zimmer, Inc.

510(k) K883665

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 NumberK883665 Date3 Feb 1989DecidedStatusActive

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  • Withdrawn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
JDC
Device class
Class II
Regulation
21 CFR Part 888.3150
Advisory committee
Orthopedic
FDA decision
SN

Overview

AI-generated summary, 19 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 Coonrad III Total Elbow is a Prosthesis, Elbow, Constrained, Cemented, designed to replace the natural elbow joint in patients with severe degenerative, traumatic, or inflammatory conditions. It provides constrained articulation to restore stability and function, particularly in cases requiring revision or primary intervention where bone integrity is compromised.

This device is supplied as a cemented, single-use implant and is intended for use in orthopedic surgical settings. It is classified as a Class II medical device under FDA regulations and requires sterile packaging for surgical use. The system is regulated under the FDA 510(k) clearance (K883665) and adheres to orthopedic surgical standards for elbow arthroplasty, with no specific MRI safety restrictions noted.

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