The following data is part of a premarket notification filed by Reliance Medical Systems, Llc with the FDA for Reliance Cervical Ibf System.
| Device ID | K120396 |
| 510k Number | K120396 |
| Device Name: | RELIANCE CERVICAL IBF SYSTEM |
| Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
| Applicant | Reliance Medical Systems, LLC 545 SOUTH 500 WEST SUITE 100 Bountiful, UT 84010 |
| Contact | Bret M Berry |
| Correspondent | Bret M Berry Reliance Medical Systems, LLC 545 SOUTH 500 WEST SUITE 100 Bountiful, UT 84010 |
| Product Code | ODP |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-02-08 |
| Decision Date | 2012-05-08 |
| Summary: | summary |