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 | K173283 |
| 510k Number | K173283 |
| 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 M. Berry |
| Correspondent | Bret M. Berry Reliance Medical Systems, LLC 545 West 500 South Suite 100 Bountiful, UT 84010 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-10-16 |
| Decision Date | 2018-01-19 |
| Summary: | summary |