The following data is part of a premarket notification filed by G Surgical Llc with the FDA for G Surgical Oct Spinal System.
| Device ID | K171834 |
| 510k Number | K171834 |
| Device Name: | G Surgical OCT Spinal System |
| Classification | Posterior Cervical 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, Inc PO Box 566 Chesterland, OH 44026 -2141 |
| Product Code | NKG |
| CFR Regulation Number | 888.3075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-20 |
| Decision Date | 2017-12-19 |
| Summary: | summary |