The following data is part of a premarket notification filed by G Surgical Llc with the FDA for G Surgical Marksman System.
| Device ID | K193219 |
| 510k Number | K193219 |
| Device Name: | G Surgical Marksman System |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | G Surgical LLC 9433 Bee Cave Road Building 3, Suite 101-A Austin, TX 78733 |
| Contact | Donald Grafton |
| Correspondent | Karen E Warden BackRoads Consulting PO Box 566 Chesterland, OH 44026 |
| Product Code | NKB |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-11-21 |
| Decision Date | 2019-12-17 |