DeviceClearance

Product code QBO— Orthopedic

Cartiva SCI Disposable Instrumentation Set

Classification name
Instruments Designed For Press-Fit Osteochondral Implants
Device class
Class 2
Regulation
21 CFR 888.4505
Advisory panel
Orthopedic
Total cleared
2
First cleared
Most recent

FDA classification definition

“The device is intended to manipulate bone and cartilage tissue or implant materials for the positioning, alignment, defect creation, or placement of press-fit osteochondral implants.”

— U.S. Food and Drug Administration, device classification record for product code QBO under 21 CFR 888.4505, via openFDA

Market context for product code QBO

FDA has cleared 2 devices under product code QBO between 2018 and 2019, 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.

Clearances per year

Top applicants under product code QBO

Recent clearances under product code QBO

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