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Genesys Spine

FDA 510(k) & PMA Approved Devices — 21 products

Total Devices21
Categories6
Latest FDA decision2025-10-22
TypeNumberDevice NameCodeDateActions
510(k) K252322 SIros-X SystemOUR2025-10-22 View
510(k) K242483 Genesys Spine AIS-C II Cervical Interbody Fusion SystemOVE2025-02-07 View
510(k) K233595 Genesys Spine Sacroiliac Joint Fusion System with NavigationOLO2024-03-29 View
510(k) K233594 Genesys Spine 3DP AIS-C II Cervical Interbody SystemOVE2023-12-13 View
510(k) K220096 Genesys Spine 3DP Lumbar Interbody SystemMAX2022-03-09 View
510(k) K191489 Genesys Spine 3DP Cervical Interbody SystemOVE2020-01-08 View
510(k) K182987 Genesys Spine 3DP Lumbar Interbody SystemMAX2019-12-12 View
510(k) K192678 Genesys Spine Binary® Lumbar Plate SystemKWQ2019-10-24 View
510(k) K191748 Genesys Spine Sacroiliac Joint Fusion SystemOUR2019-09-26 View
510(k) K192076 Binary® Anterior Cervical Plate SystemKWQ2019-08-29 View
510(k) K181295 Genesys Spine AIS-C Cervical Stand-Alone SystemOVE2018-08-29 View
510(k) K173885 Genesys Spine Binary Lumbar Plate SystemKWQ2018-04-03 View
510(k) K180056 Genesys Spine AIS-C Cervical Anchored Interbody SystemOVE2018-03-28 View
510(k) K172469 TiLock Modular Spinal SystemNKB2017-11-30 View
510(k) K171838 TiLock2 Spinal SystemNKB2017-07-19 View
510(k) K171656 Genesys Spine Apache Interbody Fusion SystemMAX2017-07-13 View
510(k) K161438 Genesys Spine Apache® Anterior Lumbar Interbody Fusion SystemMAX2016-11-08 View
510(k) K161914 Genesys Spine TiLock Cortical Spinal SystemNKB2016-08-09 View
510(k) K152099 Genesys Spine Apache® Anchored Cervical Interbody Fusion SystemOVE2016-07-28 View
510(k) K161404 Genesys Spine Apache® Lateral Lumbar Interbody Fusion SystemMAX2016-07-21 View

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