Paragon 28, Inc. - FDA 510(k) Cleared Devices
50
Total
50
Cleared
0
Denied
50 devices
Cleared
Jun 17, 2022
Baby Gorilla/Gorilla Plating System
Orthopedic
29d
Cleared
Dec 25, 2021
R3ACT Stabilization System
Orthopedic
200d
Cleared
Nov 08, 2021
Paragon 28 External Ring Fixation System
Orthopedic
59d
Cleared
Aug 30, 2021
Paratrooper Plantar Plate Repair System
Orthopedic
122d
Cleared
Jul 07, 2021
Grappler Suture Anchor System
Orthopedic
96d
Cleared
Jun 28, 2021
Phantom Hindfoot TTC/TC Nail System
Orthopedic
97d
Cleared
Mar 06, 2021
Apex 3D Total Ankle Replacement System
Orthopedic
25d
Cleared
Feb 11, 2021
TenoTac Soft Tissue Fixation System
Orthopedic
85d
Cleared
Jan 14, 2021
Maven Patient-Specific Instrumentation
Orthopedic
177d
Cleared
Dec 29, 2020
Baby Gorilla/Gorilla Plating System
Orthopedic
29d
Cleared
Nov 13, 2020
APEX 3D Total Ankle Replacement System
Orthopedic
86d
Cleared
Nov 13, 2020
Monster Screw System
Orthopedic
43d
Cleared
Jul 17, 2020
Phantom® Hindfoot TTC/TC Nail System
Orthopedic
72d
Cleared
Jul 10, 2020
Paragon 28 APEX 3D Total Ankle Replacement System
Orthopedic
259d
Cleared
Jan 31, 2020
TTC Phantom® Intramedullary Nail System
Orthopedic
175d
Cleared
Jan 24, 2020
Paratrooper Plantar Plate Repair System
Orthopedic
262d
Cleared
Sep 06, 2019
TTC Phantom Intramedullary Nail System
Orthopedic
66d
Cleared
Apr 12, 2019
Baby Gorilla/Gorilla Plating System
Orthopedic
56d
Cleared
Apr 03, 2019
Monster® Screw System
Orthopedic
28d
Cleared
Mar 01, 2019
Tenodesis Screw System
Orthopedic
60d
Cleared
Jan 25, 2019
HammerToe Compression System
Orthopedic
66d
Cleared
Jan 14, 2019
Small Bone Phantom® Intramedullary Nail System
Orthopedic
143d
Cleared
Jan 14, 2019
TenoTac Soft Tissue Fixation System
Orthopedic
90d
Cleared
Sep 07, 2018
SILVERBACK Gorilla Plating System
Orthopedic
30d
Cleared
Jun 19, 2017
Phantom Small Bone Intramedullary Nail System
Orthopedic
104d