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Waveon Fracture Repair System (Waveon Rx)

by Sonoma Orthopedic Products, Inc.

510(k) K092110

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

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK092110 Date20 Jan 2010ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 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  • Withdrawn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
HSB
Device Class
Class II
Regulation
21 CFR Part 888.3020
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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.

The Waveon Fracture Repair System (Waveon Rx) is an orthopedic device used for fracture repair. It is designed to provide stabilization and support for bone fractures during the healing process.

The device is supplied by Sonoma Orthopedic Products, Inc. and has FDA 510(k) clearance with K number K092110. It is classified as a Class II medical device and is intended for single-use in clinical settings.

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Questions

AI-generated answers, 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.

  • What is the Waveon Fracture Repair System used for?

    The Waveon Fracture Repair System is an orthopedic device designed to provide stabilization and support for bone fractures during the healing process. It helps maintain proper alignment and promotes optimal healing conditions.

  • How is the Waveon Fracture Repair System supplied?

    The device is supplied by Sonoma Orthopedic Products, Inc. It is intended for single-use in clinical settings, meaning each unit should be used for one patient procedure and then discarded according to medical waste disposal protocols.

  • What is the regulatory status of the Waveon Fracture Repair System?

    The Waveon Fracture Repair System has FDA 510(k) clearance with K number K092110. It is classified as a Class II medical device and received a decision of 'Substantially Equivalent' through the traditional clearance pathway.

  • Is the Waveon Fracture Repair System reusable?

    No, the Waveon Fracture Repair System is intended for single-use only. This design ensures sterility for each patient procedure and eliminates the need for complex reprocessing that could potentially compromise device integrity or performance.