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Ransford Cervical Fixation System

by Surgicraft, Ltd.

510(k) K965221

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 NumberK965221 Date7 Aug 1997ClearedStatusActive

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  • Withdrawn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
FDA applicant
Surgicraft , Ltd.
Device Class
Class II
Regulation
21 CFR Part 888.3050
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 Ransford Cervical Fixation System is a posterior spinal fixation orthosis designed to immobilize the spine and facilitate bony fusion. It consists of contoured stainless steel or titanium loops, rods, and cross-links that are implanted across adjacent vertebrae.

This system is used by surgeons in clinical settings and is attached to the occiput and posterior arches via sublaminar wiring or cabling. The device has received FDA 510(k) clearance under the traditional pathway.

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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 clinical purpose of the Ransford Cervical Fixation System?

    This system is a posterior spinal fixation orthosis intended to immobilize the spine. By stabilizing the area, it is designed to facilitate bony fusion between adjacent vertebrae.

  • How is the Ransford Cervical Fixation System attached to the patient?

    The system is implanted by surgeons across adjacent vertebrae. It is secured to the occiput and posterior arches using sublaminar wiring or cabling techniques.

  • What materials are used in the construction of this fixation system?

    The Ransford Cervical Fixation System is manufactured using either stainless steel or titanium. These materials are formed into contoured loops, rods, and cross-links to provide the necessary structural support for spinal immobilization.

  • What is the regulatory status of this device?

    The Ransford Cervical Fixation System has received FDA 510(k) clearance under the traditional pathway, as indicated by the K965221 submission record.