The following data is part of a premarket notification filed by Degen Medical with the FDA for F1 Mps Modular Pedicle Screw System.
| Device ID | K160926 |
| 510k Number | K160926 |
| Device Name: | F1 MPS Modular Pedicle Screw System |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | Degen Medical 1321-C North Cashua Drive Florence, SC 29501 |
| Contact | Craig Black |
| Correspondent | Linda Braddon SECURE BIOMED EVALUATIONS 7828 HICKORY FLAT HIGHWAY Suite 120 Woodstock, GA 30188 |
| Product Code | NKB |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| Subsequent Product Code | OSH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-04 |
| Decision Date | 2016-06-28 |
| Summary: | summary |