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Acuity Surgical Devices, LLC

FDA 510(k) & PMA Approved Devices — 8 products

Total Devices8
Categories4
Latest FDA decision2025-07-30
TypeNumberDevice NameCodeDateActions
510(k) K251735 Stabilis SA Cervical Stand-Alone System (Various PNs)OVE2025-07-30 View
510(k) K251335 Tera Lumbar Interbody Fusion System (Various PNs)MAX2025-06-02 View
510(k) K243386 Ventris Intervertebral Body Fusion DeviceOVD2025-04-22 View
510(k) K241413 sagAlign Lumbar Cage System (Various PNs)MAX2024-07-17 View
510(k) K230639 Align Cervical Interbody Fusion SystemODP2023-12-01 View
510(k) K222561 AlignOVD2022-09-23 View
510(k) K221535 Align Lumbar Interbody Fusion SystemMAX2022-07-22 View
510(k) K201671 A-Link ZOVD2021-05-04 View
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