DeviceClearance

Product code OBL— Orthopedic

MODIFICATION TO STAXX FX SYSTEM

Classification name
Cement, Bone, Pre-Formed, Modular, Polymeric, Vertebroplasty
Device class
Class 2
Regulation
21 CFR 888.3027
Advisory panel
Orthopedic
Total cleared
1
First cleared
Most recent

FDA classification definition

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

— U.S. Food and Drug Administration, device classification record for product code OBL under 21 CFR 888.3027, via openFDA

Market context for product code OBL

FDA has cleared 1 device under product code OBL, all in 2007, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code OBL

Recent clearances under product code OBL

Data sourced from openFDA. This site is unofficial and independent of the FDA.