Opacity+ Bone Cement

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K080873 ↗

FDA Product Code

NDN

Device Class

Class II

Regulation

21 CFR Part 888.3027

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Vertecem

  Class II

  FDA 510(k) K090435 Active Cleared 21 Dec 2009

• F20

  Class II

  FDA 510(k) K103433 Active Cleared 3 Jan 2011

• Ceraform Bone Void Filler

  Class II

  FDA 510(k) K040669 Active Cleared 3 May 2004

• Cementek Lv

  Class II

  FDA 510(k) K042911 Active Cleared 27 Dec 2004

• Cemstop Cement Restrictor

  Class II

  FDA 510(k) K032685 Active Cleared 26 Nov 2003

• Triha +

  Class II

  FDA 510(k) K031826 Active Cleared 28 Nov 2003

See all devices from Teknimed, S.A. →

• What is Opacity+ Bone Cement used for?

  Opacity+ Bone Cement is designed for palliative percutaneous cementoplasty procedures, such as vertebroplasty or kyphoplasty. It provides clear visualization during procedures due to its high concentration of radiopaque agents.

• How is Opacity+ Bone Cement supplied and is it reusable?

  The device is supplied sterile and is intended for single-use applications only. It is not reusable and must be stored according to the manufacturer's guidelines to maintain its integrity and performance.

• What is the regulatory status of Opacity+ Bone Cement?

  Opacity+ Bone Cement is regulated under FDA 510(k) authorization with a K-number of K080873. It has been determined to be substantially equivalent to predicate devices in the orthopedic device category.

• What are the key characteristics of Opacity+ Bone Cement?

  This is a self-curing, ready-to-use low-viscosity bone cement that contains a high concentration of radiopaque agents to ensure clear visualization during procedures. It is specifically formulated for use in cementoplasty procedures.