QBO — Instruments Designed For Press-Fit Osteochondral Implants Class II

FDA Device Classification

Classification Details

Product Code: QBO
Device Class: Class II
Regulation Number: 888.4505
Submission Type
Review Panel: OR
Medical Specialty: Orthopedic
Implant: No

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.

Recent 510(k) Clearances

K-Number	Applicant	Device Name	Date
K192156	cartiva	Cartiva SCI instrumentation set	September 4, 2019
K181348	cartiva	Cartiva SCI Disposable Instrumentation Set	June 20, 2018