The following data is part of a premarket notification filed by Valorus Spine with the FDA for Liberty Anterior Cervical Plate.
Device ID | K172585 |
510k Number | K172585 |
Device Name: | Liberty Anterior Cervical Plate |
Classification | Appliance, Fixation, Spinal Intervertebral Body |
Applicant | Valorus Spine 696 San Ramon Valley Blvd.,Suite 411 Danville, CA 94526 |
Contact | Leah Fero |
Correspondent | Nick Cordaro Watershed Idea Foundry 533 2nd Street Encinitas, CA 92024 |
Product Code | KWQ |
CFR Regulation Number | 888.3060 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-08-28 |
Decision Date | 2017-10-23 |
Summary: | summary |