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ISOLA Open and Closed Screws

by Acromed Corp.

510(k) K944756

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)SN Traditional NumberK944756 Date30 May 1995DecidedStatusActive

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  • Withdrawn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
MNH
Device Class
Class II
Regulation
21 CFR Part 888.3070
Advisory Committee
Orthopedic
FDA Decision
SN

Overview

AI-generated summary, 23 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 ISOLA Open and Closed Screws are orthopedic devices designed for fixation and stabilization in medical applications. They are intended for use in procedures requiring secure anchoring and support.

These screws are supplied sterile and are intended for single-use applications. They are MRI compatible and should be stored in a controlled environment to maintain integrity. The device is regulated under FDA 510(k) clearance.

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Questions

AI-generated answers, 23 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 are ISOLA Open and Closed Screws used for?

    These orthopedic devices are designed for fixation and stabilization in medical applications. They provide secure anchoring and support for procedures requiring stable internal fixation.

  • How are the ISOLA screws supplied?

    The screws are supplied sterile and are intended for single-use applications. They should be stored in a controlled environment to maintain their integrity.

  • Are ISOLA Open and Closed Screws MRI compatible?

    Yes, these screws are MRI compatible, which allows for their use in patients who may require magnetic resonance imaging scans.