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Alphatec Spine, Inc. FDA Approvals
0 new drug approvals and 38 device clearances on file. This applicant is not matched to a listed company.
Newest first
A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.
| Product |
|---|
| Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation System510(k)Jul 14, 2026Orthopedic |
| IntraOp Alignment System; CONTOUR3D Bending System510(k)Jun 25, 2026Orthopedic |
| Invictus Bands System510(k)Mar 25, 2026Orthopedic |
| Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation)510(k)Feb 19, 2026Neurology |
| SafeOp 3: Neural Informatix System510(k)Jan 11, 2026Neurology |
| Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)510(k)Aug 28, 2025Orthopedic |
| IdentiTi II Cervical Interbody System510(k)Jul 3, 2025Orthopedic |
| Calibrate Interbody Systems510(k)Mar 4, 2025 |
| IdentiTi II Interbody System510(k)Oct 4, 2024Orthopedic |
| Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody System510(k)Sep 20, 2024Orthopedic |
| Invictus® Small Stature Spinal Fixation System510(k)Jun 21, 2024Orthopedic |
| IntraOp Alignment System510(k)May 22, 2024Radiology |
| SafeOp 3: Neural Informatix Systeem510(k)Apr 19, 2024Neurology |
| Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS Interbody System; Transcend SPS Interbody System;Transcend NanoTec SPS Interbody System510(k)Feb 22, 2024Orthopedic |
| ATEC Posterior Navigated Disc Prep Instruments510(k)Nov 2, 2023Neurology |
| Calibrate CCX Interbody System510(k)Oct 13, 2023Orthopedic |
| Ascend VBR System, Ascend NanoTec VBR System510(k)Oct 6, 2023Orthopedic |
| Invictus Robotic Navigation Instruments510(k)Oct 6, 2023Neurology |
| Invictus® Spinal Fixation System510(k)Sep 27, 2023Orthopedic |
| IdentiTi ALIF Interbody Systems510(k)Sep 25, 2023Orthopedic |
| Fusion Robotic Navigation System510(k)Sep 8, 2023Neurology |
| Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody System510(k)Jul 13, 2023Orthopedic |
| ATEC Lateral Plate System510(k)May 9, 2023Orthopedic |
| Calibrate LTX Interbody System510(k)Mar 29, 2023Orthopedic |
| ATEC Lateral Navigation Instruments510(k)Mar 23, 2023Neurology |
| Invictus® Bone Cement, Invictus Spinal Fixation System510(k)Dec 20, 2022Orthopedic |
| Calibrate LTX Interbody System510(k)Nov 18, 2022Orthopedic |
| IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System, IdentiTi NanoTec Cervical Interbody System, Transcend Cervical PEEK Interbody System, Transcend NanoTec Cervical Interbody System, IdentiTi Cervical Standalone Interbody System, IdentiTi NanoTec Cervical Standalone Interbody Sytem510(k)Nov 17, 2022Orthopedic |
| ATEC IOM Accessory Instruments510(k)Sep 23, 2022Ear, Nose, Throat |
| 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, IdentiTi Cervical Standalone Interbody System, IdentiTi NanoTec Cervical Standalone Interbody System510(k)Jun 9, 2022Orthopedic |
| Invictus® Spinal Fixation System510(k)Apr 4, 2022Orthopedic |
| SafeOp 2: Neural Informatix System510(k)Mar 9, 2022Neurology |
| Insignia Anterior Cervical Plate System510(k)Dec 15, 2021Orthopedic |
| Invictus Spinal Fixation System510(k)Dec 10, 2021Orthopedic |
| ATEC Alignment App510(k)Oct 29, 2021Radiology |
| IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec Interbody System, Transcend NanoTec Interbody System510(k)Sep 22, 2021Orthopedic |
| PSX Interbody System510(k)Aug 10, 2021Orthopedic |
| IdentiTi ALIF Standalone Interbody System510(k)Apr 9, 2021Orthopedic |