The following data is part of a premarket notification filed by Wenzel Spine with the FDA for Varilift -c.
| Device ID | K120603 |
| 510k Number | K120603 |
| Device Name: | VARILIFT -C |
| Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
| Applicant | WENZEL SPINE 206 Wild Basin Road Building A, Suite 203 Austin, TX 78746 |
| Contact | Sourabh Mishra |
| Correspondent | Sourabh Mishra WENZEL SPINE 206 Wild Basin Road Building A, Suite 203 Austin, TX 78746 |
| Product Code | ODP |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-02-28 |
| Decision Date | 2013-01-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00813210020856 | K120603 | 000 |
| 00813210020207 | K120603 | 000 |
| 00813210020214 | K120603 | 000 |
| 00813210020221 | K120603 | 000 |
| 00813210020252 | K120603 | 000 |
| 00813210020764 | K120603 | 000 |
| 00813210020771 | K120603 | 000 |
| 00813210020788 | K120603 | 000 |
| 00813210020832 | K120603 | 000 |
| 00813210020849 | K120603 | 000 |
| 00813210020238 | K120603 | 000 |