The following data is part of a premarket notification filed by Surgentec, Llc with the FDA for Ion Facet Screw System.
| Device ID | K211855 |
| 510k Number | K211855 |
| Device Name: | Ion Facet Screw System |
| Classification | System, Facet Screw Spinal Device |
| Applicant | SurGenTec, LLC 911 Clint Moore Rd Boca Raton, FL 33487 |
| Contact | Andrew Shoup |
| Correspondent | Andrew Shoup SurGenTec, LLC 911 Clint Moore Rd Boca Raton, FL 33487 |
| Product Code | MRW |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-16 |
| Decision Date | 2022-02-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858406007990 | K211855 | 000 |
| 00850040139013 | K211855 | 000 |
| 00850040139020 | K211855 | 000 |
| 00850040139037 | K211855 | 000 |
| 00850040139044 | K211855 | 000 |
| 00850040139051 | K211855 | 000 |
| 00850040139068 | K211855 | 000 |
| 00850040139075 | K211855 | 000 |
| 00850040139082 | K211855 | 000 |
| 00850040139099 | K211855 | 000 |
| 00858406007952 | K211855 | 000 |
| 00858406007969 | K211855 | 000 |
| 00858406007976 | K211855 | 000 |
| 00858406007983 | K211855 | 000 |
| 00850040139006 | K211855 | 000 |