The following data is part of a premarket notification filed by Wenzel Spine with the FDA for Wenzel Spine Varilift Interbody Fusion System.
| Device ID | K100820 |
| 510k Number | K100820 |
| Device Name: | WENZEL SPINE VARILIFT INTERBODY FUSION SYSTEM |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | WENZEL SPINE 2720 BEE CAVE ROAD Austin, TX 78746 |
| Contact | Sourabh Mishra |
| Correspondent | Sourabh Mishra WENZEL SPINE 2720 BEE CAVE ROAD 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 | 2010-03-23 |
| Decision Date | 2010-08-05 |
| Summary: | summary |