Medical Device Manufacturer · US , Carlsnad , CA

Alphatec Spine - FDA 510(k) Cleared Devices

6 submissions · 6 cleared · Since 2016

Recent clearances: IdentiTi™ II ALIF Standalone Interbody System, IdentiTi Porous Ti Interbody System, Invictus Robotic Navigation Instruments

6
Total
6
Cleared
0
Denied

FDA 510(k) Regulatory Record - Alphatec Spine Orthopedic ✕

6 devices
1-6 of 6
Cleared Sep 03, 2025
IdentiTi™ II ALIF Standalone Interbody System
K251575 · OVD
Orthopedic · 104d
Cleared Feb 03, 2025
IdentiTi Porous Ti Interbody System
K241375 · MAX
Orthopedic · 264d
Cleared Jun 06, 2024
Invictus Robotic Navigation Instruments
K240951 · OLO
Orthopedic · 59d
Cleared Oct 07, 2022
IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System,...
K222028 · MAX
Orthopedic · 88d
Cleared Jun 03, 2019
Solanas® Posterior OCT Fixation System
K191185 · NKG
Orthopedic · 31d
Cleared Sep 08, 2016
Battalion Universal Spacer System
K160958 · PHM
Orthopedic · 156d
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