The following data is part of a premarket notification filed by Vertebral Technologies, Inc. with the FDA for Interfuse Intervertebral Body Fusion Device.
| Device ID | K080673 |
| 510k Number | K080673 |
| Device Name: | INTERFUSE INTERVERTEBRAL BODY FUSION DEVICE |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | VERTEBRAL TECHNOLOGIES, INC. 14289 YELLOWPINE Andover, MN 55304 |
| Contact | Philip B Jarvi |
| Correspondent | Philip B Jarvi VERTEBRAL TECHNOLOGIES, INC. 14289 YELLOWPINE Andover, MN 55304 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-10 |
| Decision Date | 2008-06-10 |
| Summary: | summary |