Alphatec Spine, Inc.

FDA Regulatory Profile

Summary

Total Recalls
45
510(k) Clearances
98
Inspections
10
Compliance Actions
3

Recent Recalls

NumberClassProductDate
Z-1343-2026Class IIATEC Lateral Navigation Disc Prep Instruments LIF NAV, OSTEOTOME 10mm REF 267-01-000-10-N UDI-DI cJanuary 2, 2026
Z-1342-2026Class IIATEC Lateral Navigation Disc Prep Instruments LIF NAV, OSTEOTOME 10mm REF 266-01-000-10-N UDI-DI cJanuary 2, 2026
Z-1065-2025Class IICalibrate CCX Interbody System for spinal fusion procedures: Implants: (1) Calibrate CCX-December 15, 2024
Z-1182-2024Class IIIdentiTi ALIF Standalone Interbody System: Part Number/Description 132-10-85-250 / IdentiTi ALIF SJanuary 26, 2024
Z-2475-2023Class IILIF AMP, Adjustable Awl, REF 117-165, Part of the AMP System. Used with Spine Lateral Interbody SystJuly 7, 2023
Z-0196-2023Class IIDisc Preparation instruments contained in the following products: CI-11050-08102515 Longer IdentiTSeptember 14, 2022
Z-1814-2021Class IIAtec Insignia Anterior Cervical Plate System, REF 136-0248 Insignia, ACP, 2-Level, 48 mm, Rx Only, NApril 26, 2021
Z-1818-2021Class IIAtec Insignia Anterior Cervical Plate System, REF 136-0354 Insignia, ACP, 3-Level, 54 mm, Rx Only, NApril 26, 2021
Z-1807-2021Class IIAtec Insignia Anterior Cervical Plate System, REF 136-0232 Insignia, ACP, 2-Level, 32 mm, Rx Only, NApril 26, 2021
Z-1800-2021Class IIAtec Insignia Anterior Cervical Plate System, REF 136-0117, Insignia, ACP, 1-Level, 17 mm, Rx Only, April 26, 2021
Z-1821-2021Class IIAtec Insignia Anterior Cervical Plate System, REF 136-0360 Insignia, ACP, 3-Level, 60 mm, Rx Only, NApril 26, 2021
Z-1804-2021Class IIAtec Insignia Anterior Cervical Plate System, REF 136-0121, Insignia, ACP, 1-Level, 21 mm, Rx Only, April 26, 2021
Z-1810-2021Class IIAtec Insignia Anterior Cervical Plate System, REF 136-0238 Insignia, ACP, 2-Level, 38 mm, Rx Only, NApril 26, 2021
Z-1806-2021Class IIAtec Insignia Anterior Cervical Plate System, REF 136-0124, Insignia, ACP, 1-Level, 24 mm, Rx Only, April 26, 2021
Z-1823-2021Class IIAtec Insignia Anterior Cervical Plate System, REF 136-0364 Insignia, ACP, 3-Level, 64 mm, Rx Only, NApril 26, 2021
Z-1811-2021Class IIAtec Insignia Anterior Cervical Plate System, REF 136-0240 Insignia, ACP, 2-Level, 40 mm, Rx Only, NApril 26, 2021
Z-1817-2021Class IIAtec Insignia Anterior Cervical Plate System, REF 136-0352 Insignia, ACP, 3-Level, 52 mm, Rx Only, NApril 26, 2021
Z-1827-2021Class IIAtec Insignia Anterior Cervical Plate System, REF 136-0482 Insignia, ACP, 4-Level, 82 mm, Rx Only, NApril 26, 2021
Z-1812-2021Class IIAtec Insignia Anterior Cervical Plate System, REF 136-0242 Insignia, ACP, 2-Level, 42 mm, Rx Only, NApril 26, 2021
Z-1803-2021Class IIAtec Insignia Anterior Cervical Plate System, REF 136-0120, Insignia, ACP, 1-Level, 20 mm, Rx Only, April 26, 2021

Recent 510(k) Clearances

K-NumberDeviceDate
K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStatiFebruary 19, 2026
K252842SafeOp 3: Neural Informatix SystemJanuary 11, 2026
K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemSeptember 3, 2025
K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)August 28, 2025
K251080IdentiTi II Cervical Interbody SystemJuly 3, 2025
K243461Calibrate Interbody SystemsMarch 4, 2025
K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi Cervical Porous Ti February 3, 2025
K242364IdentiTi™ II Interbody SystemOctober 4, 2024
K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemSeptember 20, 2024
K241519Invictus® Small Stature Spinal Fixation SystemJune 21, 2024
K240951Invictus Robotic Navigation InstrumentsJune 6, 2024
K240199IntraOp Alignment SystemMay 22, 2024
K234092SafeOp 3: Neural Informatix SysteemApril 19, 2024
K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS Interbody System; February 22, 2024
K232345ATEC Posterior Navigated Disc Prep InstrumentsNovember 2, 2023
K232504Calibrate CCX Interbody SystemOctober 13, 2023
K232044Invictus Robotic Navigation InstrumentsOctober 6, 2023
K232173Ascend VBR System, Ascend NanoTec VBR SystemOctober 6, 2023
K232275Invictus® Spinal Fixation SystemSeptember 27, 2023
K232097IdentiTi ALIF Interbody SystemsSeptember 25, 2023