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Huvexel Co. , Ltd.

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

Total Devices8
Categories6
Latest FDA decision2022-03-25
TypeNumberDevice NameCodeDateActions
510(k) K213820 BALTEUM - ONE™ Lumbar Plate SystemKWQ2022-03-25 View
510(k) K200846 Balteum™ Lumbar Plate SystemKWQ2020-05-05 View
510(k) K191477 AEON-C Stand Alone SystemOVE2019-11-13 View
510(k) K180729 FaSet Fixation SystemMRW2018-06-28 View
510(k) K173201 UNITY Sacroiliac Joint Fixation SystemOUR2018-04-26 View
510(k) K173131 Rexious Spinal Fixation SystemNKB2017-12-08 View
510(k) K173099 Fortis and Hana Anterior Cervical Plate SystemKWQ2017-11-30 View
510(k) K173080 IVA Cage Ti (ACIF, PLIF, TLIF, DLIF, and ALIF)MAX2017-10-31 View
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