The following data is part of a premarket notification filed by Reliance Medical Systems with the FDA for Reliance Spinal Screw System.
| Device ID | K101112 |
| 510k Number | K101112 |
| Device Name: | RELIANCE SPINAL SCREW SYSTEM |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | RELIANCE MEDICAL SYSTEMS 545 SOUTH 500 WEST SUITE 100 Bountiful, UT 84010 |
| Contact | Bret Barry |
| Correspondent | Bret Barry RELIANCE MEDICAL SYSTEMS 545 SOUTH 500 WEST SUITE 100 Bountiful, UT 84010 |
| Product Code | KWP |
| Subsequent Product Code | KWQ |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-04-21 |
| Decision Date | 2010-11-04 |
| Summary: | summary |