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Omnia Medical, LLC

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

Total Devices11
Categories8
Latest FDA decision2025-06-06
TypeNumberDevice NameCodeDateActions
510(k) K242431 Omnia Medical PsiF DNA™ SystemOUR2025-06-06 View
510(k) K240623 Omnia Medical TiBrid™-SA SystemOVD2024-04-24 View
510(k) K230424 Omnia Medical Coupler-A™ Anterior Lumbar Plate System; Omnia Medical Coupler-L™ Lateral Lumbar Plate SystemKWQ2023-04-12 View
510(k) K223321 Omnia Medical Coupler-C Anterior Cervical PlateKWQ2023-03-13 View
510(k) K212612 Omnia Medical TiBrid-SCOVE2022-11-15 View
510(k) K203207 Omnia Medical TiBrid-SAOVD2020-12-23 View
510(k) K192096 Omnia Medical Trauma ScrewsHWC2020-02-27 View
510(k) K190363 Omnia Medical TiBrid Cervical Cage, Omnia Medical TiBrid Lateral Cage, Omnia Medical TiBrid ALIF Cage, Omnia Medical TiBrid PLIF Cage, Omnia Medical TiBrid TLIF CageMAX2020-02-21 View
510(k) K191778 Omnia Medical VBRPLR2019-08-28 View
510(k) K183659 Omnia Medical Rotary PLIF SystemMAX2019-02-06 View
510(k) K172323 Omnia Medical VBRMQP2017-10-26 View
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