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 | K081978 |
| 510k Number | K081978 |
| Device Name: | RELIANCE SPINAL SCREW SYSTEM |
| Classification | Orthosis, Spinal Pedicle Fixation |
| Applicant | Reliance Medical Systems, LLC 2647 CASSOWARY CIR Sandy, UT 84092 -7116 |
| Contact | Bret M Berry |
| Correspondent | Bret M Berry Reliance Medical Systems, LLC 2647 CASSOWARY CIR Sandy, UT 84092 -7116 |
| Product Code | MNI |
| Subsequent Product Code | KWP |
| Subsequent Product Code | KWQ |
| Subsequent Product Code | MNH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-07-11 |
| Decision Date | 2009-03-26 |
| Summary: | summary |