The following data is part of a premarket notification filed by Vertebral Technologies, Inc. with the FDA for Interfuse Da Invertebral Body Fusion Device.
| Device ID | K110045 |
| 510k Number | K110045 |
| Device Name: | INTERFUSE DA INVERTEBRAL BODY FUSION DEVICE |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | VERTEBRAL TECHNOLOGIES, INC. 5909 Baker Road Suite 550 Minnetonka, MN 55345 |
| Contact | Suresh Ghai |
| Correspondent | Suresh Ghai VERTEBRAL TECHNOLOGIES, INC. 5909 Baker Road Suite 550 Minnetonka, MN 55345 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-01-06 |
| Decision Date | 2011-02-03 |
| Summary: | summary |