The following data is part of a premarket notification filed by Intelivation Llc with the FDA for Golden Isles Pedicle Screw System.
| Device ID | K212185 |
| 510k Number | K212185 |
| Device Name: | Golden Isles Pedicle Screw System |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | Intelivation LLC 70 Gruber Lane Saint Simons Island, GA 31522 |
| Contact | Amit Sinha |
| Correspondent | Barry Sands RQMIS, Inc. 110 Haverhill Road, Suite 524 Amesbury, MA 01913 |
| Product Code | NKB |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-07-13 |
| Decision Date | 2021-08-19 |