The following data is part of a premarket notification filed by Synthes Usa Products Llc with the FDA for Uss System.
| Device ID | K170654 |
| 510k Number | K170654 |
| Device Name: | USS System |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | Synthes USA Products LLC 325 Paramount Drive Raynham, MA 02767 |
| Contact | Eugene Bang |
| Correspondent | Eugene Bang Synthes USA Products LLC 325 Paramount Drive Raynham, MA 02767 |
| Product Code | NKB |
| Subsequent Product Code | KWP |
| Subsequent Product Code | KWQ |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-03 |
| Decision Date | 2017-03-29 |
| Summary: | summary |