The following data is part of a premarket notification filed by Zavation Llc with the FDA for Zavation Ibf Systems.
| Device ID | K112664 |
| 510k Number | K112664 |
| Device Name: | ZAVATION IBF SYSTEMS |
| Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
| Applicant | ZAVATION LLC 501 AVALON WAY Brandon, MS 39047 |
| Contact | John Walker |
| Correspondent | John Walker ZAVATION LLC 501 AVALON WAY Brandon, MS 39047 |
| Product Code | ODP |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-13 |
| Decision Date | 2011-12-23 |
| Summary: | summary |