Tracers Bone Cement Opacifier

No FDA recalls found in the data synced 11 Oct 2026.

510(k) Number

K023445 ↗

FDA Product Code

MYU

Device Class

Class II

Regulation

21 CFR Part 882.5300

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

• Clearview Plus Bone and Vertebral Body Biopsy Needles

  Class II

  FDA 510(k) K022169 Active Cleared 25 Jul 2002

• Parallax Cranioset

  Class II

  FDA 510(k) K994022 Active Cleared 31 Aug 2000

• Parallax Tracer Radiopaque Particles

  Class II

  FDA 510(k) K991893 Active Cleared 13 Aug 1999

• Parallax Bone and Vertebral Body Biopsy and Infusion Needles

  Class II

  FDA 510(k) K011206 Active Cleared 18 Jul 2001

• Tracers Ta Bone Cement Opacifier, Model Tcr-Ta

  Class II

  FDA 510(k) K033230 Active Cleared 12 Dec 2003