K192156 is an FDA 510(k) clearance for the Cartiva SCI instrumentation set. This device is classified as a Instruments Designed For Press-fit Osteochondral Implants (Class II - Special Controls, product code QBO).
Submitted by Cartiva, Inc. (Alpharetta, US). The FDA issued a Cleared decision on September 4, 2019, 26 days after receiving the submission on August 9, 2019.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.4505. 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..
| 510(k) Number | K192156 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 09, 2019 |
| Decision Date | September 04, 2019 |
| Days to Decision | 26 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | QBO - Instruments Designed For Press-fit Osteochondral Implants |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.4505 |
| 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. |