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 | K173102 |
510k Number | K173102 |
Device Name: | Reliance Cervical IBF System |
Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
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 | ODP |
CFR Regulation Number | 888.3080 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-09-29 |
Decision Date | 2017-12-29 |
Summary: | summary |