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FDA 510(k) Applications Submitted by AMI AKALLAL-ASAAD
FDA 510(k) Number
Submission Date
Device Name
Applicant
K150417
02/18/2015
ASTRA SPINE SYSTEM
SPINECRAFT LLC
K110906
03/31/2011
APEX SPINE SYSTEM
SPINECRAFT LLC
K211323
04/30/2021
ASTRA Spine System
SpineCraft, LLC
K181350
05/22/2018
ASTRA-OCT Spine System
SpineCraft LLC
K131521
05/28/2013
VELOX ANTERIOR CERVICAL PLATE SYSTEM
SPINECRAFT LLC
K211935
06/22/2021
ORIO-Ti Intervertebral Body Fusion Cage System
SpineCraft, LLC
K132603
08/20/2013
APEX SPINE SYSTEM
SPINECRAFT LLC
K062513
08/28/2006
APEX SPINE SYSTEM
SPINECRAFT, INC.
K102488
08/31/2010
APEX SPINE SYSTEM W/ COCR RODS
SPINECRAFT LLC
K092825
09/11/2009
APEX SPINE SYSTEM 5.50 MM TITANIUM ROD & POLYAXIAL SCREW WASHER
SPINECRAFT, INC.
K223273
10/24/2022
ASTRA Spine System
SpineCraft, LLC
K223301
10/27/2022
ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments System
SpineCraft, LLC
K103505
11/29/2010
ALTUM ANTERIOR CERVICAL PLATE
SPINECRAFT LLC
K143683
12/24/2014
APEX-DL Spine System
SPINECRAFT LLC
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