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 | K142269 |
510k Number | K142269 |
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 PO Box 1693 Bountiful, UT 84011 |
Product Code | ODP |
CFR Regulation Number | 888.3080 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-08-15 |
Decision Date | 2015-06-09 |
Summary: | summary |