Medical Device Manufacturer · US , Carlsnad , CA

Alphatec Spine

6 submissions · 6 cleared · Since 2016
6
Total
6
Cleared
0
Denied

Alphatec Spine — FDA 510(k) Submissions

Alphatec Spine has submitted 6 FDA 510(k) premarket notifications since 2016, of which 6 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Intervertebral Fusion Device With Bone Graft, Lumbar, Orthopedic Stereotaxic Instrument, Intervertebral Fusion Device With Integrated Fixation, Lumbar, Intervertebral Fusion Device With Bone Graft, Thoracic, Posterior Cervical Screw System . Use the specialty filter in the sidebar to narrow results.

6 devices
1–6 of 6
IdentiTi? II ALIF Standalone Interbody System; Transcend? ALIF Standalone Interbody System
K251575 · OVD Intervertebral Fusion... · Orthopedic
Sep 2025 104d
IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi Cervical Porous Ti Interbody System; IdentiTi NanoTec Cervical Interbody System; IdentiTi Cervical Standalone Interbody System; IdentiTi NanoTec Cervical Standalone Interbody System; IdentiTi ALIF Standalone Interbody System; IdentiTi NanoTec ALIF Standalone Interbody System; Transcend PEEK Interbody System; Transcend NanoTec Interbody System; Transcend Cervical PEEK Interbody System; Transcend NanoTec Cer
K241375 · MAX Intervertebral Fusion... · Orthopedic
Feb 2025 264d
Invictus Robotic Navigation Instruments
K240951 · OLO Orthopedic Stereotaxic... · Orthopedic
Jun 2024 59d
IdentiTi? Porous Ti Interbody System, IdentiTi? NanoTec? Interbody System, Transcend? PEEK Interbody System, Transcend? NanoTec? Interbody System, IdentiTi? ALIF Standalone Interbody System, IdentiTi? NanoTec? ALIF Standalone Interbody System
K222028 · MAX Intervertebral Fusion... · Orthopedic
Oct 2022 88d
Solanas? Posterior OCT Fixation System
K191185 · NKG Posterior Cervical Screw... · Orthopedic
Jun 2019 31d
Battalion Universal Spacer System
K160958 · PHM Intervertebral Fusion... · Orthopedic
Sep 2016 156d
Filters
All6 Orthopedic 6