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OSSIO , Ltd.

FDA 510(k) & PMA Approved Devices — 20 products

Total Devices20
Categories4
Latest FDA decision2026-05-01
TypeNumberDevice NameCodeDateActions
510(k) K254077 OSSIOfiber® Threaded Trimmable Fixation NailHWC2026-05-01 View
510(k) K254055 OSSIOfiber® Suture AnchorMAI2026-02-24 View
510(k) K252022 OSSIOfiber® Interference ScrewMAI2025-08-19 View
510(k) K251309 OSSIOfiber® Suture AnchorMAI2025-05-27 View
510(k) K243760 OSSIOfiber® Suture Anchor 2.5-3.5 mmMAI2025-04-03 View
510(k) K241932 OSSIOfiber® Compression StapleMNU2024-08-28 View
510(k) K241277 OSSIOfiber® Threaded Trimmable Fixation NailHWC2024-07-03 View
510(k) K233198 OSSIOfiber® Threaded Trimmable Fixation NailsHWC2024-03-08 View
510(k) K231272 OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable Fixation NailHTY2023-12-01 View
510(k) K233302 OSSIOfiber® Compression StapleMNU2023-11-16 View
510(k) K230750 OSSIOfiber® Cannulated Trimmable Fixation NailHTY2023-09-13 View
510(k) K221193 OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mmHWC2022-12-23 View
510(k) K213415 OSSIOfiber Suture AnchorMAI2022-03-28 View
510(k) K212594 OSSIOfiber® StapleMNU2022-01-21 View
510(k) K213596 OSSIOfiber Compression Screw, 3.5mmHWC2021-12-21 View
510(k) K203465 OSSIOfiber Cannulated Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, Cannulated DesignHTY2021-01-06 View
510(k) K201803 OSSIOfiber™ Hammertoe Fixation System/OSSIOfiber™ Hammertoe Fixation ImplantHTY2020-10-16 View
510(k) K193660 OSSIOfiber™ Compression ScrewsHWC2020-07-30 View
510(k) K190652 OSSIOfiber™ Hammertoe Fixation System/OSSIOfiber™ Hammertoe Fixation ImplantHTY2020-03-06 View
510(k) K181180 OSSIO™ Pin Product FamilyHTY2019-01-10 View
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