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FDA 510(k) Applications Submitted by Spinal Elements Inc.
FDA 510(k) Number
Submission Date
Device Name
Applicant
K153352
11/20/2015
Vertu« & Vertu« Ti-Bond and Crystal« & Crystal« Ti-Bond Cervical Interbody System
Spinal Elements Inc.
K150061
01/13/2015
Lucent; Lucent Ti-Bond Systems
Spinal Elements Inc.
K170235
01/25/2017
Lucent«
Spinal Elements Inc.
K160465
02/19/2016
Spinal Elements' Spinous Process Plate System
Spinal Elements Inc.
K151215
05/06/2015
Mercury Spinal System
Spinal Elements Inc.
K181837
07/10/2018
Spinal Elements Ti-Bond coated devices
Spinal Elements Inc.
K152011
07/21/2015
Lucent Intervertebral Body Fusion Device
Spinal Elements Inc.
K172967
09/26/2017
Mercury« Spinal System
Spinal Elements Inc.
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