FDA 510(k) Applications Submitted by Paragon 28, Inc.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K240594 |
03/04/2024 |
Grappler Suture Anchor R3FLEX IOL System |
Paragon 28, Inc. |
| K250641 |
03/04/2025 |
APEX 3D Total Ankle Replacement System |
Paragon 28, Inc. |
| K241262 |
05/06/2024 |
Baby Gorilla/Gorilla Plating System; Monster Screw System |
Paragon 28, Inc. |
| K231867 |
06/26/2023 |
Grappler Suture Anchor System |
Paragon 28, Inc. |
| K241864 |
06/27/2024 |
Grappler Interference Screw System |
Paragon 28, Inc. |
| K242452 |
08/19/2024 |
Monkey Bars Pin to Bar External Fixation System |
Paragon 28, Inc. |
| K232838 |
09/14/2023 |
Monkey RingsTM External Fixation 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. |
| K240259 |
01/31/2024 |
APEX 3D Total Ankle Replacement System |
Paragon 28, Inc. |
| K234128 |
12/28/2023 |
Phantom Fibula 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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