The following data is part of a premarket notification filed by Reliance Medical Systems, Llc with the FDA for Reliance Interspinous Plate System.
Device ID | K142217 |
510k Number | K142217 |
Device Name: | Reliance Interspinous Plate System |
Classification | Spinous Process Plate |
Applicant | Reliance Medical Systems, LLC 545 West 500 South, Suite 100 Bountiful, UT 84010 |
Contact | Jeremy Alsup |
Correspondent | Meredith L May EMPIRICAL TESTING CORPORATION 4628 NORTHPARK DRIVE Colorado Springs, CO 80918 |
Product Code | PEK |
CFR Regulation Number | 888.3050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-08-12 |
Decision Date | 2015-04-02 |
Summary: | summary |