OBL

Cement, Bone, Pre-Formed, Modular, Polymeric, Vertebroplasty

Product code

OBL

Device name

Cement, Bone, Pre-Formed, Modular, Polymeric, Vertebroplasty

Device class

Class 2

21 CFR

21 CFR 888.3027

Medical specialty

Orthopedic

Marketing pathway

510(K)

Flag

Implant

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification definition

Reduction of vertebral body fractures in conjunction with PMMA bone cement cleared for vertebroplasty and restoration of vertebral body height.

Definition text from the FDA device classification database (U.S. federal government work, public domain).