QBO · Class II · 21 CFR 888.4505

FDA Product Code QBO: Instruments Designed For Press-fit Osteochondral Implants

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.

Leading manufacturers include Cartiva, Inc..

2
Total
2
Cleared
28d
Avg days
2018
Since

FDA 510(k) Cleared Instruments Designed For Press-fit Osteochondral Implants Devices (Product Code QBO)

2 devices
1–2 of 2
Cleared Sep 04, 2019
Cartiva SCI instrumentation set
K192156
Cartiva, Inc.
Orthopedic · 26d
Cleared Jun 20, 2018
Cartiva SCI Disposable Instrumentation Set
K181348
Cartiva, Inc.
Orthopedic · 30d

About Product Code QBO - Regulatory Context