The following data is part of a premarket notification filed by Zavation Medical Products, Llc with the FDA for Zavation Ezspand Interbody System.
| Device ID | K220581 |
| 510k Number | K220581 |
| Device Name: | Zavation EZspand Interbody System |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| 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 | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-03-01 |
| Decision Date | 2022-06-02 |