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FDA 510(k) Applications Submitted by Julie Lamothe
FDA 510(k) Number
Submission Date
Device Name
Applicant
K150061
01/13/2015
Lucent; Lucent Ti-Bond Systems
Spinal Elements Inc.
K170235
01/25/2017
Lucent«
Spinal Elements Inc.
K190289
02/11/2019
Karma« Fixation System
Spinal Elements Inc
K160465
02/19/2016
Spinal Elements' Spinous Process Plate System
Spinal Elements Inc.
K180728
03/20/2018
Spinal Elements Cerclage System
Spinal Elements Inc
K151215
05/06/2015
Mercury Spinal System
Spinal Elements Inc.
K191576
06/14/2019
Mercury« Spinal System, Overwatch« 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.
K133218
10/18/2013
Crystal «; Mosaic «; Vertu «
SPINAL ELEMENTS, INC.
K134045
12/31/2013
ZIMMER ZFX TITANIUM ABUTMENT, BASE ABUTMENT AND ABUTMENT BLANK FOR NOBELACTIVE IMPLANT SYSTEM
ZIMMER DENTAL INC.
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