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Paragon 28, Inc.

FDA 510(k) & PMA Approved Devices — 52 products

Total Devices52
Categories10
Latest FDA decision2026-08-06
TypeNumberDevice NameCodeDateActions
510(k) K261121 Megalodon Dynamic Compression SystemJDR2026-08-06 View
510(k) K262047 Grappler Suture Anchor SystemMBI2026-08-03 View
510(k) K253886 Grappler Suture Anchor PCFD Tether SystemMBI2026-03-17 View
510(k) K253591 Phantom® Hindfoot TTC/TC Nail SystemHSB2026-03-05 View
510(k) K253613 Monkey Rings External Ring Fixation SystemKTT2025-12-19 View
510(k) K252106 External Fixation Mini Rail SystemKTT2025-09-30 View
510(k) K251862 External Fixation Bone DistractorKTT2025-08-11 View
510(k) K250952 Baby Gorilla®/Gorilla® Plating SystemHRS2025-07-18 View
510(k) K251850 Phantom® Hindfoot TTC/TC Nail SystemHSB2025-07-14 View
510(k) K250641 APEX 3D Total Ankle Replacement SystemHSN2025-05-01 View
510(k) K242452 Monkey Bars Pin to Bar External Fixation SystemKTT2024-11-01 View
510(k) K234128 Phantom Fibula Nail SystemHSB2024-08-22 View
510(k) K241864 Grappler Interference Screw SystemMBI2024-07-25 View
510(k) K240259 APEX 3D Total Ankle Replacement SystemHSN2024-06-24 View
510(k) K241262 Baby Gorilla/Gorilla Plating System; Monster Screw SystemHRS2024-06-05 View
510(k) K240594 Grappler Suture Anchor R3FLEX IOL SystemMBI2024-03-26 View
510(k) K231231 MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation DevicesHWC2023-10-12 View
510(k) K232838 Monkey RingsTM External Fixation SystemKTT2023-10-12 View
510(k) K231496 TITAN 3-D Wedge SystemPLF2023-08-22 View
510(k) K231867 Grappler Suture Anchor SystemMBI2023-08-21 View

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