The following data is part of a premarket notification filed by Presidio Surgical with the FDA for Viking Lumbar Polyaxial Screw System.
| Device ID | K180655 |
| 510k Number | K180655 |
| Device Name: | Viking Lumbar Polyaxial Screw System |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | Presidio Surgical 1451 Danville Blvd. Suite 204 Alamo, CA 94507 |
| Contact | Meredith Lee May |
| Correspondent | Meredith Lee May Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, CO 80918 |
| Product Code | NKB |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-13 |
| Decision Date | 2018-07-13 |
| Summary: | summary |