The following data is part of a premarket notification filed by Evolution Spine, Llc with the FDA for Vail Alif Buttress Plate System.
| Device ID | K180755 |
| 510k Number | K180755 |
| Device Name: | Vail ALIF Buttress Plate System |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | Evolution Spine, LLC 2300 North Haskell Ave Dallas, TX 75204 |
| Contact | Douglas Davis |
| Correspondent | Douglas Davis Evolution Spine, LLC 2300 North Haskell Ave Dallas, TX 75204 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-22 |
| Decision Date | 2018-07-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00195860010785 | K180755 | 000 |
| 00195860010624 | K180755 | 000 |
| 00195860010631 | K180755 | 000 |
| 00195860010648 | K180755 | 000 |
| 00195860010655 | K180755 | 000 |
| 00195860010662 | K180755 | 000 |
| 00195860010679 | K180755 | 000 |
| 00195860010686 | K180755 | 000 |
| 00195860010693 | K180755 | 000 |
| 00195860010709 | K180755 | 000 |
| 00195860010716 | K180755 | 000 |
| 00195860010723 | K180755 | 000 |
| 00195860010730 | K180755 | 000 |
| 00195860010747 | K180755 | 000 |
| 00195860010754 | K180755 | 000 |
| 00195860010761 | K180755 | 000 |
| 00195860010778 | K180755 | 000 |
| 00195860010617 | K180755 | 000 |