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Rexious Spinal Fixation System

by Dio Medical Corporation

510(k) K222415

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 NumberK222415 Date25 Oct 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  • Withdrawn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
NKB
Device class
Class II
Regulation
21 CFR Part 888.3070
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 Rexious Spinal Fixation System is an orthopedic device designed for spinal fixation procedures. It features a polyaxial spinal screw with a double inner cap design that allows the screw head to be semi-fixed before final fixation and provides an average angle variability of 50 degrees.

This system is supplied for use in surgical settings and has received FDA 510(k) clearance. It is categorized as a Class 2 orthopedic device.

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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 is the primary function of the Rexious Spinal Fixation System?

    The Rexious Spinal Fixation System is designed for use in spinal fixation procedures. It utilizes a polyaxial spinal screw with a double inner cap design, which allows the screw head to be semi-fixed prior to final fixation.

  • What is the range of motion for the Rexious spinal screws?

    The system provides an average angle variability of 50 degrees, allowing for flexibility during the surgical fixation process.

  • What is the regulatory status of this device?

    The Rexious Spinal Fixation System has received FDA 510(k) clearance and is categorized as a Class 2 orthopedic device.