The following data is part of a premarket notification filed by Theken Spine Llc with the FDA for Vu C*pod Intervertebral Body Fusion Device.
| Device ID | K111675 |
| 510k Number | K111675 |
| Device Name: | VU C*POD INTERVERTEBRAL BODY FUSION DEVICE |
| Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
| Applicant | THEKEN SPINE LLC 1153 MEDINA RD. Medina, OH 44256 -0000 |
| Contact | Dale Davison |
| Correspondent | Dale Davison THEKEN SPINE LLC 1153 MEDINA RD. Medina, OH 44256 -0000 |
| Product Code | ODP |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-06-15 |
| Decision Date | 2011-08-02 |
| Summary: | summary |