Paragon 28, Inc. - FDA 510(k) Cleared Devices
50
Total
50
Cleared
0
Denied
FDA 510(k) cleared devices by Paragon 28, Inc. Orthopedic ✕
50 devices
Cleared
Mar 17, 2026
Grappler Suture Anchor PCFD Tether System
Orthopedic
103d
Cleared
Mar 05, 2026
Phantom® Hindfoot TTC/TC Nail System
Orthopedic
108d
Cleared
Dec 19, 2025
Monkey Rings External Ring Fixation System
Orthopedic
31d
Cleared
Sep 30, 2025
External Fixation Mini Rail System
Orthopedic
89d
Cleared
Aug 11, 2025
External Fixation Bone Distractor
Orthopedic
55d
Cleared
Jul 18, 2025
Baby Gorilla®/Gorilla® Plating System
Orthopedic
112d
Cleared
Jul 14, 2025
Phantom® Hindfoot TTC/TC Nail System
Orthopedic
28d
Cleared
May 01, 2025
APEX 3D Total Ankle Replacement System
Orthopedic
58d
Cleared
Nov 01, 2024
Monkey Bars Pin to Bar External Fixation System
Orthopedic
74d
Cleared
Aug 22, 2024
Phantom Fibula Nail System
Orthopedic
238d
Cleared
Jul 25, 2024
Grappler Interference Screw System
Orthopedic
28d
Cleared
Jun 24, 2024
APEX 3D Total Ankle Replacement System
Orthopedic
145d
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