Skip to content

F20

by Teknimed, S.A.

510(k) K103433

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 NumberK103433 Date3 Jan 2011ClearedStatusActive

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  • Withdrawn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
NDN
Device Class
Class II
Regulation
21 CFR Part 888.3027
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

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

F20 is a bone cement intended for use in percutaneous cementoplasty procedures, such as vertebroplasty or kyphoplasty. It functions as a substance to replace cortical or cancellous bone in a vertebral body.

This sterile, self-curing, medium viscosity bone cement is supplied as a ready-to-use product. It features a high content of radiopaque agent and is designed for low exothermic properties during the curing process. The device is subject to FDA 510(k) authorization.

Other devices from Teknimed, S.A.

See all devices from Teknimed, S.A. →

Questions

AI-generated answers, 6 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 F20 bone cement used for?

    F20 is a sterile, self-curing bone cement designed for percutaneous cementoplasty procedures, including vertebroplasty and kyphoplasty. It serves as a replacement for cortical or cancellous bone within a vertebral body.

  • What are the key physical characteristics of F20?

    The device is supplied as a ready-to-use product. It is formulated with a high content of radiopaque agent and is engineered to exhibit low exothermic properties during the curing process.

  • What is the regulatory status and viscosity of F20?

    F20 is a medium viscosity bone cement. It has received FDA 510(k) authorization for its intended use in orthopedic procedures.