DeviceClearance

Product code MBP— Orthopedic

DBX STRIP

Classification name
Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)
Device class
Class 2
Regulation
21 CFR 888.3045
Advisory panel
Orthopedic
Total cleared
31
First cleared
Most recent

Market context for product code MBP

FDA has cleared 31 devices under product code MBP between 2005 and 2024, filed by 17 applicant companies. 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.

Clearances per year

Top applicants under product code MBP

Recent clearances under product code MBP

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