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Charlotte Compression Plate

by Wrightmedicaltechnologyinc 510(k)

Active United States

510(k) K051908

Overview

The Charlotte Compression Plate is a metallic bone fixation device classified as a Plate, Fixation, Bone. It is designed to stabilize fractured or surgically altered bones in orthopedic procedures, providing mechanical support to promote proper alignment and healing during foot surgery.

This device is supplied in three distinct sizes and paired with 2.7mm locking screws ranging from 12mm to 24mm in length. It is intended for single-use and falls under FDA 510(k) clearance (K051908) with a Special Controls classification (HRS). The device is regulated under the Orthopedic review panel and is intended for use in sterile surgical environments.

AI-generated from registry data, 19 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK051908 Date10 Aug 2005ClearedStatusActive

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
SESE Substantially Equivalent

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Questions

  • What types of bone fractures or surgical alterations is the Charlotte Compression Plate designed to stabilize, and how does it achieve this?

    The Charlotte Compression Plate is specifically designed to stabilize fractured or surgically altered bones during foot surgery. It achieves this by providing mechanical support to maintain proper alignment of the bone fragments, promoting optimal healing conditions through compression and fixation.

  • How many sizes are available for the Charlotte Compression Plate, and what accessories come with it?

    The Charlotte Compression Plate comes in three distinct sizes. It is paired with 2.7mm locking screws, which are available in lengths ranging from 12mm to 24mm, ensuring versatility for different surgical needs.

  • Is the Charlotte Compression Plate intended for single-use or repeated use, and why?

    The Charlotte Compression Plate is intended for single-use. This is likely due to its classification as a sterile surgical device, where reusing metallic implants could compromise sterility, patient safety, and the integrity of the fixation.

  • What type of screws are used with the Charlotte Compression Plate, and what lengths are available?

    The Charlotte Compression Plate is designed to be used with 2.7mm locking screws. These screws come in lengths ranging from 12mm to 24mm, allowing for flexibility in surgical applications to accommodate varying bone depths and fixation requirements.

  • In what kind of environment is the Charlotte Compression Plate intended to be used, and why?

    The Charlotte Compression Plate is intended for use in sterile surgical environments, as it is a metallic bone fixation device. Sterility is critical in orthopedic procedures to prevent infection and ensure proper healing of the bone.