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Cutting Edge Spine, LLC

FDA 510(k) & PMA Approved Devices — 9 products

Total Devices9
Categories3
Latest FDA decision2025-03-12
TypeNumberDevice NameCodeDateActions
510(k) K250605 EVOL® ha – Hyper C Cervical Interbody Fusion SystemODP2025-03-12 View
510(k) K230689 T-FIX™ 3DSI Joint Fusion SystemOUR2023-04-05 View
510(k) K214123 T-FIX® 3DSI Joint Fusion SystemOUR2022-06-24 View
510(k) K200991 EVOL Spinal Interbody SystemMAX2020-05-13 View
510(k) K200552 EVOS Lumbar Interbody SystemMAX2020-04-02 View
510(k) K192497 EVOL ha - D Lateral Interbody Fusion SystemMAX2020-01-06 View
510(k) K190025 EVOL® -SI Joint Fusion SystemOUR2019-08-12 View
510(k) K180674 EVOL® ha-C Cervical Interbody Fusion SystemODP2018-06-25 View
510(k) K180891 EVOL Spinal Interbody System, EVOS Lumbar Interbody SystemMAX2018-05-04 View
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