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Rod for Rachis Surgery

by Sofamor Co.

510(k) K843687

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 NumberK843687 Date10 Jan 1985ClearedStatusActive

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  • Withdrawn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
Device Class
Class II
Regulation
21 CFR Part 888.3050
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

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

A device for supporting the rachis, installed by surgery. It is used for consolidating a rachis that needs consolidation, such as in accidental fracture, or for correcting and supporting a rachis suffering from curvatures such as scoliosis or kyphosis.

Manufactured by Sofamor Co., this device received FDA 510(k) clearance (K843687) on January 10, 1985, under product code KWP and was reviewed by the Orthopedic advisory committee. It is supplied as a surgical implant for use in spinal procedures.

Other devices from Sofamor Co.

Questions

AI-generated answers, 25 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 Rod for Rachis Surgery used for?

    It is used to support and stabilize the rachis (spine) in cases requiring consolidation, such as accidental fractures, or to correct and support spinal deformities like scoliosis or kyphosis during surgical procedures.

  • How is the Rod for Rachis Surgery supplied and intended for use?

    It is supplied as a surgical implant intended for use in spinal procedures to provide structural support and stabilization of the vertebral column during surgery.

  • Is the Rod for Rachis Surgery a single-use or reusable device?

    As a surgical implant designed for permanent implantation to support spinal structure, it is intended for single-use implantation and is not designed for removal or reuse after implantation.