The following data is part of a premarket notification filed by Arftx Medical Llc with the FDA for Artfx Corpectomy Cages (espinax And Distractania Corpectomy Cages).
| Device ID | K211892 |
| 510k Number | K211892 |
| Device Name: | ArtFx Corpectomy Cages (Espinax And Distractania Corpectomy Cages) |
| Classification | Spinal Vertebral Body Replacement Device |
| Applicant | ARFTX Medical LLC 50 Laura Street #2524 Jacksonville, FL 32202 |
| Contact | Ozgen Ozfidan |
| Correspondent | Ozgen Ozfidan ARFTX Medical LLC 50 Laura Street #2524 Jacksonville, FL 32202 |
| Product Code | MQP |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-21 |
| Decision Date | 2022-10-06 |