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Acryl-X System

by Sonokinetics, Inc.

510(k) K911548

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 NumberK911548 Date28 Jun 1991ClearedStatusActive

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  • Withdrawn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)

Full name
Acryl-X System Tm
510(k) Number
FDA Product Code
JDX
Device Class
Class II
Regulation
21 CFR Part 888.4580
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 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 Acryl-X System is a surgical instrument classified as a sonic and accessory attachment. It is designed for use in orthopedic medical procedures.

This device is regulated under FDA 510(k) clearance K911548. It is categorized as a Class 2 medical device.

Other devices from Sonokinetics, Inc.

  • Acryl-X II System

    Class II

  • Sonotome

    Unclassified

Questions

AI-generated answers, 26 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 intended use of the Acryl-X System?

    The Acryl-X System is a surgical instrument classified as a sonic and accessory attachment. It is specifically designed for use during orthopedic medical procedures.

  • Is the Acryl-X System regulated by the FDA?

    Yes, the device is regulated under FDA 510(k) clearance K911548. It is categorized as a Class 2 medical device, which indicates it has been found substantially equivalent to other legally marketed devices.

  • What is the regulatory classification of this device?

    The Acryl-X System is classified as a Class 2 medical device. This classification is based on its designation as a sonic surgical instrument and accessory attachment, falling under regulation number 888.4580.