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Alphatec Spine, Inc.

FDA 510(k) & PMA Approved Devices — 61 products

Total Devices61
Categories17
Latest FDA decision2026-07-14
TypeNumberDevice NameCodeDateActions
510(k) K261284 Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemNKB2026-07-14 View
510(k) K253216 IntraOp Alignment System; CONTOUR3D Bending SystemSIN2026-06-25 View
510(k) K253615 Invictus Bands SystemOWI2026-03-25 View
510(k) K252597 Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation)OLO2026-02-19 View
510(k) K252842 SafeOp 3: Neural Informatix SystemGWF2026-01-11 View
510(k) K251965 Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)KWQ2025-08-28 View
510(k) K251080 IdentiTi II Cervical Interbody SystemODP2025-07-03 View
510(k) K243461 Calibrate Interbody Systems2025-03-04 View
510(k) K242364 IdentiTi™ II Interbody SystemMAX2024-10-04 View
510(k) K242147 Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemMAX2024-09-20 View
510(k) K241519 Invictus® Small Stature Spinal Fixation SystemNKB2024-06-21 View
510(k) K240199 IntraOp Alignment SystemOWB2024-05-22 View
510(k) K234092 SafeOp 3: Neural Informatix SysteemGWF2024-04-19 View
510(k) K233640 Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS Interbody System; Transcend SPS Interbody System;Transcend NanoTec SPS Interbody SystemKWQ2024-02-22 View
510(k) K232345 ATEC Posterior Navigated Disc Prep InstrumentsOLO2023-11-02 View
510(k) K232504 Calibrate CCX Interbody SystemMAX2023-10-13 View
510(k) K232173 Ascend VBR System, Ascend NanoTec VBR SystemMQP2023-10-06 View
510(k) K232044 Invictus Robotic Navigation InstrumentsOLO2023-10-06 View
510(k) K232275 Invictus® Spinal Fixation SystemNKB2023-09-27 View
510(k) K232097 IdentiTi ALIF Interbody SystemsOVD2023-09-25 View

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