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Huvexel Co. , Ltd.

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

Total Devices8
Categories6
Latest Approval2022-03-25
TypeNumberDevice NameCodeDate
510(k) K213820 BALTEUM - ONE™ Lumbar Plate System KWQ 2022-03-25 View
510(k) K200846 Balteum™ Lumbar Plate System KWQ 2020-05-05 View
510(k) K191477 AEON-C Stand Alone System OVE 2019-11-13 View
510(k) K180729 FaSet Fixation System MRW 2018-06-28 View
510(k) K173201 UNITY Sacroiliac Joint Fixation System OUR 2018-04-26 View
510(k) K173131 Rexious Spinal Fixation System NKB 2017-12-08 View
510(k) K173099 Fortis and Hana Anterior Cervical Plate System KWQ 2017-11-30 View
510(k) K173080 IVA Cage Ti (ACIF, PLIF, TLIF, DLIF, and ALIF) MAX 2017-10-31 View
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