The following data is part of a premarket notification filed by Zavation Medical Products Llc with the FDA for Zavation Spinal System.
| Device ID | K190361 |
| 510k Number | K190361 |
| Device Name: | Zavation Spinal System |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | Zavation Medical Products LLC 220 Lakeland Parkway Flowood, MS 39232 |
| Contact | Matt Jones |
| Correspondent | Matt Jones Zavation Medical Products LLC 220 Lakeland Parkway Flowood, MS 39232 |
| Product Code | NKB |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-15 |
| Decision Date | 2019-03-18 |