The following data is part of a premarket notification filed by Spinal Devices, Llc with the FDA for Phenix Cervical Interbody Device.
| Device ID | K083167 |
| 510k Number | K083167 |
| Device Name: | PHENIX CERVICAL INTERBODY DEVICE |
| Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
| Applicant | SPINAL DEVICES, LLC 13540 GUILD AVE Apple Valley, MN 55124 |
| Contact | Richard Jansen |
| Correspondent | Richard Jansen SPINAL DEVICES, LLC 13540 GUILD AVE Apple Valley, MN 55124 |
| Product Code | ODP |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-10-27 |
| Decision Date | 2009-01-13 |
| Summary: | summary |