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Alphatec Spine, Inc.

FDA Regulatory Profile

Alphatec Spine, Inc. appears in FDA public data with 45 recalls, 101 510(k) clearances, 10 FDA inspections, and 3 compliance actions on record. Its most recent recall (Z-1343-2026, Class II) was initiated on January 2, 2026. Its most recent 510(k) clearance was granted on July 14, 2026.

Summary

Total Recalls
45
510(k) Clearances
101
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-1808-2021Class IIAtec Insignia Anterior Cervical Plate System, REF 136-0234 Insignia, ACP, 2-Level, 34 mm, Rx Only, NApril 26, 2021
Z-1820-2021Class IIAtec Insignia Anterior Cervical Plate System, REF 136-0358 Insignia, ACP, 3-Level, 58 mm, Rx Only, NApril 26, 2021
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-1812-2021Class IIAtec Insignia Anterior Cervical Plate System, REF 136-0242 Insignia, ACP, 2-Level, 42 mm, Rx Only, NApril 26, 2021
Z-1799-2021Class IIAtec Insignia Anterior Cervical Plate System, REF 136-0116, Insignia, ACP, 1-Level, 16 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-1825-2021Class IIAtec Insignia Anterior Cervical Plate System, REF 136-0474 Insignia, ACP, 4-Level, 74 mm, Rx Only, NApril 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-1824-2021Class IIAtec Insignia Anterior Cervical Plate System, REF 136-0468 Insignia, ACP, 4-Level, 68 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-1811-2021Class IIAtec Insignia Anterior Cervical Plate System, REF 136-0240 Insignia, ACP, 2-Level, 40 mm, Rx Only, NApril 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-1816-2021Class IIAtec Insignia Anterior Cervical Plate System, REF 136-0350 Insignia, ACP, 3-Level, 50 mm, Rx Only, NApril 26, 2021

Recent 510(k) Clearances

K-NumberDeviceDate
K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemJuly 14, 2026
K253216IntraOp Alignment System; CONTOUR3D Bending SystemJune 25, 2026
K253615Invictus Bands SystemMarch 25, 2026
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

FDA data resources