The following data is part of a premarket notification filed by Frontier Medical Devices, Inc. with the FDA for Frontier Medical Devices Posterior Cable Screw System.
| Device ID | K151346 |
| 510k Number | K151346 |
| Device Name: | Frontier Medical Devices Posterior Cable Screw System |
| Classification | Cerclage, Fixation |
| Applicant | FRONTIER MEDICAL DEVICES, INC. 512 FOURTH STREET Gwinn, MI 49841 |
| Contact | Bethany Byman |
| Correspondent | Bethany Byman FRONTIER MEDICAL DEVICES, INC. 512 FOURTH STREET Gwinn, MI 49841 |
| Product Code | JDQ |
| CFR Regulation Number | 888.3010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-05-20 |
| Decision Date | 2015-08-20 |
| Summary: | summary |