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 | K151900 |
| 510k Number | K151900 |
| 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 | Beckinam Nowatzke |
| Correspondent | Beckinam Nowatzke 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 | 2015-07-10 |
| Decision Date | 2015-12-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00813210020641 | K151900 | 000 |
| 00813210020085 | K151900 | 000 |
| 00813210020092 | K151900 | 000 |
| 00813210020108 | K151900 | 000 |
| 00813210020115 | K151900 | 000 |
| 00813210020122 | K151900 | 000 |
| 00813210020139 | K151900 | 000 |
| 00813210020146 | K151900 | 000 |
| 00813210020153 | K151900 | 000 |
| 00813210020160 | K151900 | 000 |
| 00813210020177 | K151900 | 000 |
| 00813210020337 | K151900 | 000 |
| 00813210020344 | K151900 | 000 |
| 00813210020351 | K151900 | 000 |
| 00813210020368 | K151900 | 000 |
| 00813210020375 | K151900 | 000 |
| 00813210020078 | K151900 | 000 |