The following data is part of a premarket notification filed by Reliance Medical Systems, Llc with the FDA for Reliance Spinal Screw System.
| Device ID | K162066 |
| 510k Number | K162066 |
| Device Name: | Reliance Spinal Screw System |
| Classification | Orthosis, Spondylolisthesis Spinal Fixation |
| Applicant | Reliance Medical Systems, LLC 545 West 500 South Suite 100 Bountiful, UT 84010 |
| Contact | Bret M. Berry |
| Correspondent | Bret M. Berry Reliance Medical Systems, LLC 545 West 500 South, Suite 100 Bountiful, UT 84010 |
| Product Code | MNH |
| Subsequent Product Code | KWP |
| Subsequent Product Code | KWQ |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-26 |
| Decision Date | 2016-12-02 |
| Summary: | summary |