The following data is part of a premarket notification filed by Cartiva, Inc. with the FDA for Cartiva Sci Instrumentation Set.
| Device ID | K192156 |
| 510k Number | K192156 |
| Device Name: | Cartiva SCI Instrumentation Set |
| Classification | Instruments Designed For Press-fit Osteochondral Implants |
| Applicant | Cartiva, Inc. 6120 Windward Parkway, Suite 220 Alpharetta, GA 30005 |
| Contact | Shriya Kafle |
| Correspondent | Shriya Kafle Cartiva, Inc. 6120 Windward Parkway, Suite 220 Alpharetta, GA 30005 |
| Product Code | QBO |
| CFR Regulation Number | 888.4505 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-09 |
| Decision Date | 2019-09-04 |
| Summary: | summary |