The following data is part of a premarket notification filed by Reliance Medical Systems, Llc with the FDA for Reliance Posterior Cervical-thoracic System.
Device ID | K142867 |
510k Number | K142867 |
Device Name: | Reliance Posterior Cervical-Thoracic System |
Classification | Appliance, Fixation, Spinal Interlaminal |
Applicant | Reliance Medical Systems, LLC 545 West 500 South, Suite 100 Bountiful, UT 84010 |
Contact | Bret M. Berry |
Correspondent | Bret Berry Reliance Medical Systems, LLC P.O. Box 1693 Bountiful, UT 84010 |
Product Code | KWP |
CFR Regulation Number | 888.3050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-10-01 |
Decision Date | 2015-04-29 |
Summary: | summary |