K223303 is an FDA 510(k) clearance for the Spinery™ RF Ablation System. This device is classified as a Electrosurgical, Cutting & Coagulation & Accessories (Class II - Special Controls, product code GEI).
Submitted by Axon Spine Medical System (Pompei, IT). The FDA issued a Cleared decision on August 30, 2023, 307 days after receiving the submission on October 27, 2022.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 878.4400. Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf)..
| 510(k) Number | K223303 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 27, 2022 |
| Decision Date | August 30, 2023 |
| Days to Decision | 307 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | GEI - Electrosurgical, Cutting & Coagulation & Accessories |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4400 |
| Definition | Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf). |