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Small Straight Plate

by Onyx Medical Corp. 510(k)

Active United States

510(k) K931689

Overview

The Small Straight Plate is an orthopedic device used for surgical fixation. It is designed to provide stabilization for bone fractures or other orthopedic conditions.

This device is supplied by Onyx Medical Corp. and is authorized under FDA 510(k) clearance K931689 with product code HRS. The device is intended for use in orthopedic procedures and is available in various sizes as specified by the manufacturer.

AI-generated from registry data, 28 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SN Traditional NumberK931689 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 Small Straight Plate used for?

    The Small Straight Plate is an orthopedic device designed for surgical fixation to provide stabilization for bone fractures or other orthopedic conditions during orthopedic procedures.

  • How is the Small Straight Plate supplied?

    The Small Straight Plate is supplied by Onyx Medical Corp. and is available in various sizes as specified by the manufacturer to accommodate different clinical needs.

  • What is the regulatory status of the Small Straight Plate?

    The Small Straight Plate is authorized under FDA 510(k) clearance K931689 with product code HRS, indicating it is substantially equivalent for some indications in orthopedic procedures.

  • Is the Small Straight Plate reusable or single-use?

    The device data does not specify whether the Small Straight Plate is designed for single-use or reuse. Clinicians should refer to the manufacturer's instructions for use to determine the appropriate handling protocol.