K222572 is an FDA 510(k) clearance for the FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, and BALTEUM™ & BALTEUM-ONE™ Lumbar Plate System. This device is classified as a Appliance, Fixation, Spinal Intervertebral Body (Class II - Special Controls, product code KWQ).
Submitted by Dio Medical Corporation (East Norriton, US). The FDA issued a Cleared decision on October 18, 2022, 54 days after receiving the submission on August 25, 2022.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3060.
| 510(k) Number | K222572 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 25, 2022 |
| Decision Date | October 18, 2022 |
| Days to Decision | 54 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | KWQ - Appliance, Fixation, Spinal Intervertebral Body |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3060 |