The following data is part of a premarket notification filed by Wenzel Spine with the FDA for Varilift Cervical Interbody Fusion System.
| Device ID | K111123 |
| 510k Number | K111123 |
| Device Name: | VARILIFT CERVICAL INTERBODY FUSION SYSTEM |
| Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
| Applicant | WENZEL SPINE 1001 OAKWOOD BLVD Round Rock, TX 78681 |
| Contact | Sourabh Mishra |
| Correspondent | Sourabh Mishra WENZEL SPINE 1001 OAKWOOD BLVD Round Rock, TX 78681 |
| Product Code | ODP |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-04-21 |
| Decision Date | 2011-12-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00813210020061 | K111123 | 000 |
| 00813210020054 | K111123 | 000 |
| 00813210020047 | K111123 | 000 |
| 00813210020030 | K111123 | 000 |