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Cloverleaf Plate

by Onyx Medical Corp. 510(k)

Active United States

510(k) K931683

Overview

The Cloverleaf Plate is an orthopedic device used for bone fixation. It is designed to provide structural support in skeletal applications.

This device is supplied non-sterile and is intended for reusable use. It is not MRI safe. No specific sizes are provided in the data. Authorization is based on FDA 510(k) clearance under K931683.

AI-generated from registry data, 23 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SN Traditional NumberK931683 Date25 Apr 1994DecidedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
HRS
Device Class
Class II
Regulation
21 CFR Part 888.3030
Advisory Committee
Orthopedic
FDA Decision
SN

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Questions

  • What is the Cloverleaf Plate used for?

    The Cloverleaf Plate is an orthopedic device designed to provide structural support in skeletal applications, specifically for bone fixation procedures where rigid internal fixation is required to stabilize fractures or osteotomies.

  • Is the Cloverleaf Plate sterile or non-sterile, and is it intended for single-use or reuse?

    The Cloverleaf Plate is supplied non-sterile and is intended for reusable use, meaning it must be cleaned and sterilized by the healthcare facility before each surgical procedure according to established reprocessing protocols.

  • What regulatory pathway was used for the Cloverleaf Plate's authorization?

    The Cloverleaf Plate received authorization through the FDA 510(k) clearance process under submission number K931683, demonstrating substantial equivalence to a legally marketed predicate device for certain orthopedic indications.

  • Is the Cloverleaf Plate safe to use in an MRI environment?

    The Cloverleaf Plate is not MRI safe, meaning it should not be used in patients undergoing magnetic resonance imaging due to potential risks of device movement, heating, or image artifact caused by its metallic composition.

  • Are specific sizes or models of the Cloverleaf Plate provided in the device data?

    No specific sizes, models, or reference numbers for the Cloverleaf Plate are provided in the device data; the authorization and description refer to the device generically without detailing dimensional variations or product line extensions.