The following data is part of a premarket notification filed by Reliance Medical Systems, Llc with the FDA for Reliance Anterior Cervical Plate.
Device ID | K140742 |
510k Number | K140742 |
Device Name: | RELIANCE ANTERIOR CERVICAL PLATE |
Classification | Appliance, Fixation, Spinal Intervertebral Body |
Applicant | Reliance Medical Systems, LLC P.O. BOX 1693 Bountiful, UT 84010 |
Contact | Bret M Berry |
Correspondent | Bret M Berry Reliance Medical Systems, LLC P.O. BOX 1693 Bountiful, UT 84010 |
Product Code | KWQ |
CFR Regulation Number | 888.3060 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-03-25 |
Decision Date | 2014-04-25 |
Summary: | summary |