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Cannulated Screws

by Maxxion Medical, LLC

510(k) K213614

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 NumberK213614 Date3 Aug 2022ClearedStatusActive

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  • Withdrawn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
HWC
Device Class
Class II
Regulation
21 CFR Part 888.3040
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 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 Cannulated Screws are a type of screw, fixation, bone device, classified as Class II with special controls. They are designed to provide fixation in various anatomies and are available in different diameters and types, including Cannulated Screw, Double Compression Cannulated Screw, and Cannulated Compression Taper Screw. The screws are made of Titanium Alloy according to the standard ASTM F136.

The Cannulated Screws are provided in non-sterile condition and are available in various sizes to accommodate different patient anatomies. They have been cleared by the FDA with a 510(k) clearance, specifically K213614, and are classified under product code HWC. The devices are intended for use in orthopedic applications, as indicated by their review by the Orthopedic advisory committee.

Questions

AI-generated answers, 24 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 Cannulated Screws used for?

    Cannulated Screws are used to provide fixation in various anatomies, specifically in orthopedic applications.

  • What material are the Cannulated Screws made of?

    The Cannulated Screws are made of Titanium Alloy according to the standard ASTM F136.

  • Are the Cannulated Screws supplied sterile?

    No, the Cannulated Screws are provided in non-sterile condition.

  • What sizes are the Cannulated Screws available in?

    The Cannulated Screws are available in various sizes to accommodate different patient anatomies.