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SCS CLARIS SPINAL SYSTEM, REXTENDED OMNIAXIAL CONNECTOR-, MEDIUM - Extended Omniaxialo

by Ortho Tec, LLC

510(k) K021919

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 · Special NumberK021919 Date3 Jul 2002ClearedStatusActive

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  • Withdrawn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
Models / Variants
Extended Omniaxialo
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.

The SCS Claris Spinal System, Extended Omniaxial Connector, Medium, Model CO05 is a spinal hardware component used to connect rods and screws within the SCS Claris Spinal System. It is manufactured from titanium alloy and is available in medium size as specified in the device designation.

This device is supplied as a component of the SCS Claris Spinal System and is intended for use in spinal fixation procedures. It received FDA 510(k) clearance under K021919, classified as substantially equivalent with product code KWP, and was cleared on July 3, 2002. The device is reusable and non-sterile, supplied by the manufacturer for use in clinical settings under standard storage conditions.

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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 SCS Claris Spinal System Extended Omniaxial Connector, Medium, Model CO05 used for?

    It is a spinal hardware component used to connect rods and screws within the SCS Claris Spinal System during spinal fixation procedures, providing structural stability in vertebral column fixation.

  • Is the SCS Claris Spinal System Extended Omniaxial Connector, Medium, Model CO05 sterile or non-sterile when supplied?

    The device is supplied non-sterile by the manufacturer and must be sterilized by the user prior to implantation, as it is intended for reuse after proper cleaning and sterilization cycles.

  • What material is the SCS Claris Spinal System Extended Omniaxial Connector, Medium, Model CO05 made from, and what size is it?

    It is manufactured from titanium alloy and is available in medium size, as specified in the device designation, ensuring biocompatibility and mechanical strength for spinal implantation.

  • How is the SCS Claris Spinal System Extended Omniaxial Connector, Medium, Model CO05 supplied and stored?

    It is supplied as a component of the SCS Claris Spinal System for use in clinical settings and should be stored under standard conditions, following the manufacturer’s instructions for handling and storage prior to sterilization and use.