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Alphatec Spine, Inc.

27 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix System recall (Z-2793-2026)Alphatec Spine, Inc.2026-07-23
ATEC Lateral Navigation Disc Prep Instruments LIF NAV, OSTEOTOME 10mm REF 266-01-000-10-N recall (Z-1342-2026)Alphatec Spine, Inc.2026-02-11
ATEC Lateral Navigation Disc Prep Instruments LIF NAV, OSTEOTOME 10mm REF 267-01-000-10-N recall (Z-1343-2026)Alphatec Spine, Inc.2026-02-11
Calibrate CCX Interbody System for spinal fusion procedures: Implants: (1) Calibrate CCX-O recall (Z-1065-2025)Alphatec Spine, Inc.2025-01-30
IdentiTi ALIF Standalone Interbody System: Part Number/Description 132-10-85-250 / IdentiT recall (Z-1182-2024)Alphatec Spine, Inc.2024-02-23
LIF AMP, Adjustable Awl, REF 117-165, Part of the AMP System. Used with Spine Lateral Inte recall (Z-2475-2023)Alphatec Spine, Inc.2023-08-28
Disc Preparation instruments contained in the following products: CI-11050-08102515 Longer recall (Z-0196-2023)Alphatec Spine, Inc.2022-11-08
Arsenal Spinal Fixation System, Set Screw, Part No. 47127 Product Usage: Usage: The Arsena recall (Z-0592-2017)Alphatec Spine, Inc.2016-11-16
4.0mm Variable Angle, Self-Drilling Hexalobe Screw, 14mm Alphatec Spine Solutions for the recall (Z-1547-2015)Alphatec Spine, Inc.2015-04-29
Solanas 2.1mm FIXED DEPTH DRILL, 10mm, Part No. 63928-10. Component of the SOLANAS III Pos recall (Z-2092-2014)Alphatec Spine, Inc.2014-07-22
Illico Ti Cannulated Polyaxial Screw 7.5mm X 40mm. The Illico MIS Posterior Fixation Syste recall (Z-2086-2013)Alphatec Spine, Inc.2013-08-27
Leucadia Autolok" Polyaxial Pedicle Screw System. Intended to help provide correction, imm recall (Z-1421-2013)Alphatec Spine, Inc.2013-05-28
ILLICO Straight CP TI Rod, -5.5MM x 110M; REF#73601-110; Qty 1; LBL-005; REV.B; RX ONLY; A recall (Z-0967-2013)Alphatec Spine, Inc.2013-03-18
TI Standard Polyaxial Screw Assembly 6.5MM x 55MM. Part # 62065-55. Subsequent Product Cod recall (Z-0269-2013)Alphatec Spine, Inc.2012-11-08
ILLlCO MIS Posterior Fixation System, Bone-screw Internal Spinal Fixation System, Orthosis recall (Z-0168-2013)Alphatec Spine, Inc.2012-10-29
TRESTLE LUXE Anterior Cervical Plating System, Product code KWQ. 510(k) K102820. The TREST recall (Z-2273-2012)Alphatec Spine, Inc.2012-08-27
SOLUS Anterior Lumbar Interbody Fusion Spinal Spacer System, Solus Proximal/Distal Deploym recall (Z-1676-2012)Alphatec Spine, Inc.2012-05-29
Solanas Posterior Stabilization System Part Number: 63920. Solanas Posterior Stabilization recall (Z-0932-2012)Alphatec Spine, Inc.2012-01-31
Trestle Anterior Cervical Plate 1-level assembly, Part Number: 61001-026. Alphatec Spine, recall (Z-1746-2010)Alphatec Spine, Inc.2010-06-02
Alphatec Spine Solanas Titanium Pedicle Screw, Part Number 63035-12 recall (Z-0502-2010)Alphatec Spine, Inc.2009-12-14
Alphatec Spine Solanas Titanium Pedicle Screw Part Number 63035-14 recall (Z-0503-2010)Alphatec Spine, Inc.2009-12-14
ILLICO Posterior Thoracolumbar Access Retractor, Part Number: 73520 The ILLICO Posterior T recall (Z-0498-2010)Alphatec Spine, Inc.2009-12-11
Zodiac Polyaxial Spinal Fixation System. A spinal interlaminal fixation orthosis is a devi recall (Z-0491-2010)Alphatec Spine, Inc.2009-12-07
Alphatec Spine, Inc., NOVEL SPINAL SPACER SYSTEM, Part Number(s): 64817-010, 64817-012, 64 recall (Z-0190-2010)Alphatec Spine, Inc.2009-11-12
ROC Lumbar bolt caddy, Part Number: 81997-01-05. Sterilization container for ROC bolts/scr recall (Z-0036-2010)Alphatec Spine, Inc.2009-10-08
Novel PEEK VBR XS 16-22 MM, S-5, 20MM, Part Number: 64733-120. Indicated for use in the th recall (Z-0507-2009)Alphatec Spine, Inc.2008-12-31
Novel PEEK VBR XS 16-22 MM, S-5, 26MM, Part Numbers : 64753-126. Indicated for use in the recall (Z-0508-2009)Alphatec Spine, Inc.2008-12-31

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Every clearance here is in the API, with alerts when new ones post.