Skip to content

Arthrex Fracture Plates

by Arthrex, Inc. 2 variants

510(k) K151732

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

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK151732 Date28 Aug 2015ClearedStatusActive

Official records

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  • Withdrawn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
HRS
Device class
Class II
Regulation
21 CFR Part 888.3030
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

Arthrex Fracture Plates are orthopedic devices used for fracture fixation. These plates are designed to provide stabilization for bone fractures during the healing process.

The plates are supplied in various sizes and are intended for single-use or reusable applications depending on the specific model. They are MRI conditional and should be stored according to the manufacturer's instructions. The device has FDA 510K clearance under product code HRS.

Other devices from Arthrex, Inc.

See all devices from Arthrex, Inc. →