Medical Device Manufacturer · US , Carlsbad , CA

Alphatec Spine, Inc. - FDA 510(k) Cleared Devices

92 submissions · 92 cleared · Since 2005
92
Total
92
Cleared
0
Denied
84 devices
26-50 of 84
Cleared Dec 10, 2021
Invictus Spinal Fixation System
K213460 · NKB
Orthopedic · 44d
Cleared Sep 22, 2021
IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System,...
K211805 · MAX
Orthopedic · 103d
Cleared Aug 10, 2021
PSX Interbody System
K211873 · MAX
Orthopedic · 54d
Cleared Apr 09, 2021
IdentiTi ALIF Standalone Interbody System
K203742 · OVD
Orthopedic · 108d
Cleared Dec 18, 2020
IdentiTi Cervical Standalone Interbody System
K202812 · OVE
Orthopedic · 85d
Cleared Dec 18, 2020
Invictus™ OCT Spinal Fixation System
K203125 · NKG
Orthopedic · 60d
Cleared Nov 23, 2020
Invictus™ Spinal Fixation System
K203056 · NKB
Orthopedic · 46d
Cleared Nov 06, 2020
ATEC Lateral Interbody System
K202587 · MAX
Orthopedic · 59d
Cleared Oct 15, 2020
Invictus™ OsseoScrew® System
K202327 · NKB
Orthopedic · 59d
Cleared May 22, 2020
Invictus™ CT Spinal Fixation System
K200936 · NKG
Orthopedic · 44d
Cleared May 21, 2020
Insignia™ Anterior Cervical Plate System
K200995 · KWQ
Orthopedic · 35d
Cleared Dec 12, 2019
Invictus™ Spinal Fixation System
K192938 · NKB
Orthopedic · 55d
Cleared Aug 12, 2019
ATEC Lateral Interbody System
K191311 · MAX
Orthopedic · 89d
Cleared Mar 01, 2019
IdentiTi Porous Ti Interbody System
K183705 · MAX
Orthopedic · 60d
Cleared Nov 27, 2018
ATEC ALIF and LLIF Spacer System
K182746 · MAX
Orthopedic · 60d
Cleared Nov 09, 2018
Aspida® Anterior Lumbar Plating System
K182808 · KWQ
Orthopedic · 37d
Cleared Sep 25, 2018
OsseoScrew System
K181980 · NKB
Orthopedic · 62d
Cleared Aug 21, 2018
ATEC Cervical Spacer System
K181435 · ODP
Orthopedic · 81d
Cleared Aug 09, 2018
Kodiak Spinal Fixation System
K181677 · NKB
Orthopedic · 44d
Cleared Jul 25, 2018
ATEC ALIF Spacer System
K181453 · MAX
Orthopedic · 54d
Cleared May 31, 2018
ATEC Universal Spacer System
K180480 · PHM
Orthopedic · 97d
Cleared Nov 30, 2017
Solanas® Posterior Stabilization System
K173522 · NKB
Orthopedic · 16d
Cleared Aug 24, 2016
XYcor® Expandable Spinal Spacer System
K160646 · MAX
Orthopedic · 170d
Cleared Jun 10, 2016
Arsenal Spinal Fixation System
K161363 · NKB
Orthopedic · 24d
Cleared Apr 29, 2016
Alphatec Navigation Instruments
K153603 · OLO
Orthopedic · 134d

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