The following data is part of a premarket notification filed by Reliance Medical Systems Llc with the FDA for Reliance Lumbar Ibf System.
| Device ID | K183049 |
| 510k Number | K183049 |
| Device Name: | Reliance Lumbar IBF System |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | Reliance Medical Systems LLC 545 West 500 South Suite 100 Bountiful, UT 84010 |
| Contact | Bret Berry |
| Correspondent | Bret Berry Reliance Medical Systems LLC 545 West 500 South Suite 100 Bountiful, UT 84010 |
| Product Code | MAX |
| Subsequent Product Code | ODP |
| Subsequent Product Code | OVE |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-02 |
| Decision Date | 2019-02-15 |
| Summary: | summary |