The following data is part of a premarket notification filed by Vertebral Technologies, Inc. with the FDA for Interfuse L Intervertebral Body Fusion Device.
| Device ID | K131540 |
| 510k Number | K131540 |
| Device Name: | INTERFUSE L INTERVERTEBRAL 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-29 |
| Decision Date | 2013-09-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00819475010922 | K131540 | 000 |
| 00819475010755 | K131540 | 000 |
| 00819475010748 | K131540 | 000 |
| 00819475010731 | K131540 | 000 |
| 00819475010724 | K131540 | 000 |
| 00819475010717 | K131540 | 000 |
| 00819475010700 | K131540 | 000 |
| 00819475010694 | K131540 | 000 |
| 00819475010687 | K131540 | 000 |
| 00819475010670 | K131540 | 000 |
| 00819475010663 | K131540 | 000 |
| 00819475010656 | K131540 | 000 |
| 00819475010649 | K131540 | 000 |
| 00819475010632 | K131540 | 000 |
| 00819475010625 | K131540 | 000 |
| 00819475010762 | K131540 | 000 |
| 00819475010779 | K131540 | 000 |
| 00819475010915 | K131540 | 000 |
| 00819475010908 | K131540 | 000 |
| 00819475010892 | K131540 | 000 |
| 00819475010885 | K131540 | 000 |
| 00819475010878 | K131540 | 000 |
| 00819475010861 | K131540 | 000 |
| 00819475010854 | K131540 | 000 |
| 00819475010847 | K131540 | 000 |
| 00819475010830 | K131540 | 000 |
| 00819475010823 | K131540 | 000 |
| 00819475010816 | K131540 | 000 |
| 00819475010809 | K131540 | 000 |
| 00819475010793 | K131540 | 000 |
| 00819475010786 | K131540 | 000 |
| 00819475010618 | K131540 | 000 |