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Paragon 28, Inc.

FDA 510(k) & PMA Approved Devices — 50 products

Total Devices50
Categories10
Latest Approval2026-03-17
TypeNumberDevice NameCodeDate
510(k) K253886 Grappler Suture Anchor PCFD Tether System MBI 2026-03-17 View
510(k) K253591 Phantom® Hindfoot TTC/TC Nail System HSB 2026-03-05 View
510(k) K253613 Monkey Rings External Ring Fixation System KTT 2025-12-19 View
510(k) K252106 External Fixation Mini Rail System KTT 2025-09-30 View
510(k) K251862 External Fixation Bone Distractor KTT 2025-08-11 View
510(k) K250952 Baby Gorilla®/Gorilla® Plating System HRS 2025-07-18 View
510(k) K251850 Phantom® Hindfoot TTC/TC Nail System HSB 2025-07-14 View
510(k) K250641 APEX 3D Total Ankle Replacement System HSN 2025-05-01 View
510(k) K242452 Monkey Bars Pin to Bar External Fixation System KTT 2024-11-01 View
510(k) K234128 Phantom Fibula Nail System HSB 2024-08-22 View
510(k) K241864 Grappler Interference Screw System MBI 2024-07-25 View
510(k) K240259 APEX 3D Total Ankle Replacement System HSN 2024-06-24 View
510(k) K241262 Baby Gorilla/Gorilla Plating System; Monster Screw System HRS 2024-06-05 View
510(k) K240594 Grappler Suture Anchor R3FLEX IOL System MBI 2024-03-26 View
510(k) K231231 MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation Devices HWC 2023-10-12 View
510(k) K232838 Monkey RingsTM External Fixation System KTT 2023-10-12 View
510(k) K231496 TITAN 3-D Wedge System PLF 2023-08-22 View
510(k) K231867 Grappler Suture Anchor System MBI 2023-08-21 View
510(k) K230550 JAWS Nitinol Staple System JDR 2023-05-11 View
510(k) K223589 Grappler Suture Anchor R3FLEX IOL System MBI 2023-03-03 View
510(k) K223056 JAWS Nitinol Staple System JDR 2023-02-16 View
510(k) K223184 Phantom Metatarsal Shortening System HWC 2022-12-16 View
510(k) K223227 MAVEN™ Patient-Specific Instrumentation HSN 2022-11-17 View
510(k) K222091 Grappler Suture Anchor System MBI 2022-09-14 View
510(k) K222194 Baby Gorilla®/Gorilla® Plating System HRS 2022-08-19 View
510(k) K221465 Baby Gorilla/Gorilla Plating System HRS 2022-06-17 View
510(k) K211770 R3ACT Stabilization System HWC 2021-12-25 View
510(k) K212895 Paragon 28 External Ring Fixation System KTT 2021-11-08 View
510(k) K211322 Paratrooper Plantar Plate Repair System MBI 2021-08-30 View
510(k) K211002 Grappler Suture Anchor System MBI 2021-07-07 View
510(k) K210869 Phantom Hindfoot TTC/TC Nail System HSB 2021-06-28 View
510(k) K210390 Apex 3D Total Ankle Replacement System HSN 2021-03-06 View
510(k) K203385 TenoTac Soft Tissue Fixation System MBI 2021-02-11 View
510(k) K202019 Maven Patient-Specific Instrumentation HSN 2021-01-14 View
510(k) K203511 Baby Gorilla/Gorilla Plating System HRS 2020-12-29 View
510(k) K203011 Monster Screw System HWC 2020-11-13 View
510(k) K202373 APEX 3D Total Ankle Replacement System HSN 2020-11-13 View
510(k) K201227 Phantom® Hindfoot TTC/TC Nail System HSB 2020-07-17 View
510(k) K192994 Paragon 28 APEX 3D Total Ankle Replacement System HSN 2020-07-10 View
510(k) K192163 TTC Phantom® Intramedullary Nail System HSB 2020-01-31 View
510(k) K191227 Paratrooper Plantar Plate Repair System MBI 2020-01-24 View
510(k) K191782 TTC Phantom Intramedullary Nail System HSB 2019-09-06 View
510(k) K190365 Baby Gorilla/Gorilla Plating System HRS 2019-04-12 View
510(k) K190586 Monster® Screw System HWC 2019-04-03 View
510(k) K183690 Tenodesis Screw System MBI 2019-03-01 View
510(k) K183228 HammerToe Compression System HTY 2019-01-25 View
510(k) K182898 TenoTac Soft Tissue Fixation System MBI 2019-01-14 View
510(k) K182307 Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail System HSB 2019-01-14 View
510(k) K182148 SILVERBACK Gorilla Plating System HWC 2018-09-07 View
510(k) K170693 Phantom Small Bone Intramedullary Nail System KTW 2017-06-19 View
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