The following data is part of a premarket notification filed by G Surgical Llc with the FDA for G Surgical Marksman Mis System.
| Device ID | K161516 |
| 510k Number | K161516 |
| Device Name: | G Surgical Marksman MIS System |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | G SURGICAL LLC 5757 Central Ave, Suite G Boulder, CO 80301 |
| Contact | Donald Grafton |
| Correspondent | Karen E. Warden, Ph.d. BackRoads Consulting Inc. P.O. Box 566 Chesterland, OH 44026 |
| Product Code | NKB |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-02 |
| Decision Date | 2016-08-25 |
| Summary: | summary |