OBM

Cement, Bone, Vertebroplasty, Pre-Formed, Modular

Product code
OBM
Device name
Cement, Bone, Vertebroplasty, Pre-Formed, Modular
Device class
Class 2
21 CFR
21 CFR 888.3027
Medical specialty
Orthopedic
Marketing pathway
510(K)
Flag
Implant

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).

Official FDA classification page: OBM
Classification and pathway per current FDA publications. Data from openFDA (CC0).