FDA 510(k) Applications Submitted by Paragon 28, Inc.
FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
K231867 |
06/26/2023 |
Grappler Suture Anchor System |
Paragon 28, Inc. |
K190365 |
02/15/2019 |
Baby Gorilla/Gorilla Plating System |
Paragon 28, Inc. |
K190586 |
03/06/2019 |
Monster« Screw System |
Paragon 28, Inc. |
K191227 |
05/07/2019 |
Paratrooper Plantar Plate Repair System |
Paragon 28, Inc. |
K191782 |
07/02/2019 |
TTC Phantom Intramedullary Nail System |
Paragon 28, Inc. |
K182148 |
08/08/2018 |
SILVERBACK Gorilla Plating System |
Paragon 28, Inc. |
K192994 |
10/25/2019 |
Paragon 28 APEX 3D Total Ankle Replacement System |
Paragon 28, Inc. |
K183228 |
11/20/2018 |
HammerToe Compression System |
Paragon 28, Inc. |
K170693 |
03/07/2017 |
Phantom Small Bone Intramedullary Nail System |
Paragon 28, Inc. |
K210390 |
02/09/2021 |
Apex 3D Total Ankle Replacement System |
Paragon 28, Inc. |
K210869 |
03/23/2021 |
Phantom Hindfoot TTC/TC Nail System |
Paragon 28, Inc. |
K211002 |
04/02/2021 |
Grappler Suture Anchor System |
Paragon 28, Inc. |
K211322 |
04/30/2021 |
Paratrooper Plantar Plate Repair System |
Paragon 28, Inc. |
K201227 |
05/06/2020 |
Phantom« Hindfoot TTC/TC Nail System |
Paragon 28, Inc. |
K221465 |
05/19/2022 |
Baby Gorilla/Gorilla Plating System |
Paragon 28, Inc. |
K211770 |
06/08/2021 |
R3ACT Stabilization System |
Paragon 28, Inc. |
K222091 |
07/15/2022 |
Grappler Suture Anchor System |
Paragon 28, Inc. |
K202019 |
07/21/2020 |
Maven Patient-Specific Instrumentation |
Paragon 28, Inc. |
K222194 |
07/22/2022 |
Baby Gorilla«/Gorilla« Plating System |
Paragon 28, Inc. |
K192163 |
08/09/2019 |
TTC Phantom« Intramedullary Nail System |
Paragon 28, Inc. |
K202373 |
08/19/2020 |
APEX 3D Total Ankle Replacement System |
Paragon 28, Inc. |
K223056 |
09/30/2022 |
JAWS Nitinol Staple System |
Paragon 28, Inc. |
K203011 |
10/01/2020 |
Monster Screw System |
Paragon 28, Inc. |
K223184 |
10/12/2022 |
Phantom Metatarsal Shortening System |
Paragon 28, Inc. |
K203511 |
11/30/2020 |
Baby Gorilla/Gorilla Plating System |
Paragon 28, Inc. |
K223589 |
12/01/2022 |
Grappler Suture Anchor R3FLEX IOL System |
Paragon 28, Inc. |
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