The following data is part of a premarket notification filed by Zavation, Llc with the FDA for Zavation Ibf.
| Device ID | K162206 |
| 510k Number | K162206 |
| Device Name: | Zavation IBF |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | Zavation, LLC 220 Lakeland Pkwy Flowood, MS 39232 |
| Contact | Lawrence Walker |
| Correspondent | Lawrence Walker Zavation, LLC 220 Lakeland Pkwy 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 | 2016-08-05 |
| Decision Date | 2017-04-04 |
| Summary: | summary |