The following data is part of a premarket notification filed by Wenzel Spine, Inc. with the FDA for Varilift-l Interbody Fusion Device.
| Device ID | K131296 |
| 510k Number | K131296 |
| Device Name: | VARILIFT-L INTERBODY FUSION DEVICE |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | WENZEL SPINE, INC. 206 WILD BASIN RD, BLDG A, STE 203 Austin, TX 78746 |
| Contact | Sandie Roth |
| Correspondent | Sandie Roth WENZEL SPINE, INC. 206 WILD BASIN RD, BLDG A, STE 203 Austin, TX 78746 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-06 |
| Decision Date | 2013-09-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00813210020566 | K131296 | 000 |
| 00813210020559 | K131296 | 000 |
| 00813210020474 | K131296 | 000 |
| 00813210020467 | K131296 | 000 |
| 00813210020450 | K131296 | 000 |
| 00813210020443 | K131296 | 000 |
| 00813210020023 | K131296 | 000 |
| 00813210020016 | K131296 | 000 |
| 00813210020009 | K131296 | 000 |