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Abbott Spine

16 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
PathFinder Cannulated T-Handle Bone Awl, Part Number 1155-2; distributed by Abbott Spine, recall (Z-1784-2008)Abbott Spine2008-09-05
InCompass Spinal Fixation System T-Handle Driver; Part #2151-4 (9.5" shaft) and 2151-5 (13 recall (Z-1592-2008)Abbott Spine2008-09-01
PathFinder Spinal Fixation System T-Handle Driver; Part 2151-7 (13" shaft); Non-sterile, R recall (Z-1593-2008)Abbott Spine2008-09-01
Sequoia Spinal System Surgical Kits; Pedicle screw spinal system; Non-sterile (kits intend recall (Z-1479-2008)Abbott Spine2008-07-23
Comfort T-Handle Hudson Connector with Impactor Cap; Part #1006-1; handle is component of recall (Z-0880-2008)Abbott Spine2008-02-13
PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stablization system, Part N recall (Z-0004-2008)Abbott Spine2007-10-02
PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stabilization system, Part recall (Z-0005-2008)Abbott Spine2007-10-02
TraXis Fixed Trial in sizes: 7mm, 9mm, 11mm, 13mm and 15mm; part of TraXis vertebral body recall (Z-0354-2007)Abbott Spine2007-01-17
TraXis Fixed Rasp in sizes: 7mm, 9mm, 11mm, 13mm and 15mm; for use with TraXis vertebral b recall (Z-0355-2007)Abbott Spine2007-01-17
Stericover/ Sterile Disposible Polyethylene Drape ---Universal Video Camera/ Laser Arm Equ recall (Z-1154-06)Abbott Spine2006-06-17
TraXis Vue Spinal Implant System, Part #2601-090921 recall (Z-0502-06)Abbott Spine2006-02-07
SC-AcuFix Core Instruments Surgical Techniques covering SC-AcuFix SlimLine, SlimLine Hybri recall (Z-0292-06)Abbott Spine2005-12-17
SC-AcuFix Core Instruments Surgical Techniques covering SC-AcuFix SlimLine and SlimLine Hy recall (Z-0293-06)Abbott Spine2005-12-17
SC-AcuFix Core Instruments Surgical Techniques covering SC-AcuFix Corpectomy Anterior Cerv recall (Z-0294-06)Abbott Spine2005-12-17
SC-AcuFix Core Instruments Surgical Techniques covering SC-AcuFix ThinLine Anterior Cervic recall (Z-0295-06)Abbott Spine2005-12-17
SC-AcuFix Core Instruments Surgical Techniques covering SC-AcuFix Ant-Cer Anterior Cervica recall (Z-0296-06)Abbott Spine2005-12-17

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