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Champy Bone Plates & Bone Screws

by Advanced Biosearch Assn.

510(k) K855030

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK855030 Date30 Jan 1986ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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
JEY
Device Class
Class II
Regulation
21 CFR Part 872.4760
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

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 Champy Bone Plates and Bone Screws are orthopedic fixation devices designed for internal fixation of bone fractures. These devices consist of metallic plates and screws used to stabilize and align bone fragments, promoting proper healing in orthopedic and dental surgical procedures.

These devices are supplied as reusable surgical instruments and are classified under the FDA’s Special Controls for Bone Fixation Devices (product code JEY). They are intended for use in controlled surgical environments and are regulated under the FDA’s 510(k) clearance process, with a decision date of January 30, 1986. The devices are manufactured by Advanced Biosearch Assn. and are categorized under the Dental advisory committee, though their primary application aligns with orthopedic fixation.

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