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Synthes Universal Spine Rod and Screw Fixation Sys

by Synthes (Usa)

510(k) K922855

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 NumberK922855 Date24 Jun 1993ClearedStatusActive

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  • Withdrawn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
KWQ
Device Class
Class II
Regulation
21 CFR Part 888.3060
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Synthes Universal Spine Rod and Screw Fixation Sys is a pedicle screw system intended for spinal fixation. It provides compatible posterior rods, connectors, and screws that can be used with 5.0 mm or 6.0 mm diameter rods to achieve segmental stabilization of the spine.

The system was cleared through the FDA 510(k) traditional clearance pathway (decision date 1993‑06‑24, decision code SESE) and is identified by product code KWQ and K‑number K922855. It is supplied as a complete fixation set for surgical use and is regulated as a medical device in the United States.

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Questions

AI-generated answers, 1 Oct 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 Synthes Universal Spine Rod and Screw Fixation System used for?

    The Synthes Universal Spine Rod and Screw Fixation System is a pedicle screw system intended for spinal fixation. It provides compatible posterior rods, connectors, and screws that can be used with 5.0mm or 6.0mm diameter rods to achieve segmental stabilization of the spine.

  • How is the Synthes Universal Spine Rod and Screw Fixation System supplied?

    The system is supplied as a complete fixation set for surgical use. It includes all necessary components for spinal fixation procedures, though specific contents may vary depending on the surgical requirements.

  • What regulatory pathway was used for clearance of this device?

    The system was cleared through the FDA 510(k) traditional clearance pathway with a decision date of June 24, 1993. It is identified by product code KWQ and K-number K922855, and is regulated as a medical device in the United States.

  • Can the Synthes Universal Spine Rod and Screw Fixation System be reused?

    The device is supplied as a complete fixation set for surgical use, but the description does not specify whether it is designed for single-use or multiple uses. Reuse would depend on the specific hospital protocols and manufacturer recommendations.