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 | K160463 |
| 510k Number | K160463 |
| 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 | 2016-02-19 |
| Decision Date | 2016-05-20 |
| Summary: | summary |