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S.M.A.I.O

FDA 510(k) & PMA Approved Devices — 11 products

Total Devices11
Categories2
Latest FDA decision2026-07-01
TypeNumberDevice NameCodeDateActions
510(k) K253802 KHEIRON® Spinal Fixation System, including patient specific K-RODNKB2026-07-01 View
510(k) K260786 KHEIRON® Spinal Fixation System, including patient specific K-RODNKB2026-04-03 View
510(k) K253990 KHEIRON® Spinal Fixation System, including patient specific K-RODNKB2026-01-07 View
510(k) K253721 KHEIRON® Spinal Fixation System, including patient specific K-RODNKB2025-12-17 View
510(k) K251804 KHEIRON® Spinal Fixation System, including patient specific K-RODNKB2025-07-08 View
510(k) K232650 KHEIRON® Spinal Fixation System, including patient specific K-RODNKB2023-09-29 View
510(k) K223841 KBA3DLLZ2023-05-30 View
510(k) K211981 KHEIRON® Spinal Fixation SystemNKB2022-06-09 View
510(k) K213975 KEOPS Balance Analyzer 3DLLZ2022-05-06 View
510(k) K211414 KHEIRON Spinal Fixation SystemNKB2021-08-10 View
510(k) K201659 KHEIRON® Spinal Fixation SystemNKB2020-10-05 View
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