The following data is part of a premarket notification filed by Lntelivation, Llc with the FDA for Advantage-c Peek Cervical Lnterbody Fusion Device.
| Device ID | K211501 |
| 510k Number | K211501 |
| Device Name: | Advantage-C PEEK Cervical Lnterbody Fusion Device |
| Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
| Applicant | lntelivation, LLC 70 Gruber Lane Saint Simons Island, GA 31522 |
| Contact | Jack Griffis |
| Correspondent | Jack Griffis lntelivation, LLC 70 Gruber Lane Saint Simons Island, GA 31522 |
| Product Code | ODP |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-05-14 |
| Decision Date | 2021-08-24 |