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Corelink, LLC

FDA 510(k) & PMA Approved Devices — 23 products

Total Devices23
Categories10
Latest FDA decision2023-12-08
TypeNumberDevice NameCodeDateActions
510(k) K231743 F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro Lateral Plate SystemMAX2023-12-08 View
510(k) K231494 CoreLink Robotic Navigation InstrumentsOLO2023-10-27 View
510(k) K232116 CoreLink Navigation InstrumentsOLO2023-08-16 View
510(k) K230329 F3D Interbody SystemODP2023-06-06 View
510(k) K230880 CoreLink Navigation InstrumentsOLO2023-05-02 View
510(k) K223708 Entasis 3D Dual-Lead Sacroiliac Implant SystemOUR2023-03-21 View
510(k) K221776 NextGen Pedicle Screw SystemNKB2022-08-09 View
510(k) K220973 CoreLink Navigation InstrumentsOLO2022-06-01 View
510(k) K211417 F3D-C2 Cervical Stand-Alone SystemOVE2022-02-04 View
510(k) K214059 CoreLink Navigation InstrumentsOLO2022-01-19 View
510(k) K212825 CoreLink Navigation InstrumentsOLO2021-10-13 View
510(k) K210539 CoreLink Midline Fixation SystemNKB2021-04-15 View
510(k) K202637 F3D Corpectomy SystemMQP2020-12-23 View
510(k) K200087 F3D Cervical Stand-Alone Interbody Fusion SystemOVE2020-06-15 View
510(k) K200863 Tiger® Occipital-Cervical-Thoracic Spinal Fixation SystemNKG2020-04-28 View
510(k) K182731 Corelink Navigation InstrumentsOLO2019-12-13 View
510(k) K190016 Lateral Plate SystemKWQ2019-06-12 View
510(k) K183239 CoreLink F3D™ Lateral SystemMAX2018-12-19 View
510(k) K180814 CoreLink® M3™ Stand-Alone Anterior Lumbar SystemOVD2018-08-10 View
510(k) K180556 Corelink Foundation 3D Anterior Lumbar SystemMAX2018-07-27 View

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