Skip to content

Acromed Beaded Sublaminar Wire

by Acromed Corp.

510(k) K895439

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 NumberK895439 Date22 Nov 1989ClearedStatusActive

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  • Withdrawn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
KWP
Device Class
Class II
Regulation
21 CFR Part 888.3050
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 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 Acromed Beaded Sublaminar Wire is a spinal fixation device classified under Appliance, Fixation, Spinal Interlaminal. It is designed to provide internal support and stabilization by passing beneath the laminae of vertebrae, securing them in place to facilitate spinal alignment and fusion procedures.

This device is intended for single-use in orthopedic surgical settings and has received FDA 510(k) clearance under the Traditional pathway. Supplied sterile, it is regulated under classification KWP and was first submitted to the FDA in 1989. No third-party review was conducted, and its specifications align with orthopedic spinal fixation standards.

Other devices from Acromed Corp.

See all devices from Acromed Corp. →

Questions

AI-generated answers, 19 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 Acromed Beaded Sublaminar Wire used for in spinal surgery?

    The Acromed Beaded Sublaminar Wire is designed to provide internal support and stabilization by passing beneath the laminae of vertebrae. It helps secure the vertebrae in place to assist with spinal alignment and fusion procedures, ensuring stability during recovery.

  • Is the Acromed Beaded Sublaminar Wire intended for reuse or single-use?

    The Acromed Beaded Sublaminar Wire is explicitly intended for single-use in orthopedic surgical settings. This is standard for spinal fixation devices to maintain sterility and safety, preventing cross-contamination between patients.

  • How is the Acromed Beaded Sublaminar Wire supplied, and is it sterile?

    The device is supplied sterile directly from the manufacturer, Acromed Corp., ensuring it is ready for immediate use in surgical procedures without additional sterilization steps.

  • What regulatory pathway did the Acromed Beaded Sublaminar Wire follow for FDA clearance?

    The device received FDA clearance under the Traditional 510(k) pathway, classified as substantially equivalent to a predicate device. It was submitted in 1989 and cleared in November of the same year, with no third-party review involved.