The following data is part of a premarket notification filed by Arthrex Inc. with the FDA for Arthrex Vortex Threaded Bone Marrow Recovery Needle.
| Device ID | K213213 |
| 510k Number | K213213 |
| Device Name: | Arthrex Vortex Threaded Bone Marrow Recovery Needle |
| Classification | Instrument, Biopsy |
| Applicant | Arthrex Inc. 1370 Creekside Boulevard Naples, FL 34108 -1945 |
| Contact | Nick Moore |
| Correspondent | Nick Moore Arthrex Inc. 1370 Creekside Boulevard Naples, FL 34108 -1945 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-29 |
| Decision Date | 2021-11-19 |