Medical Device Manufacturer · US , Englewood , CO

Paragon 28, Inc.

49 submissions · 49 cleared · Since 2017
49
Total
49
Cleared
0
Denied

Paragon 28, Inc. — FDA 510(k) Submissions

Paragon 28, Inc. has submitted 49 FDA 510(k) premarket notifications since 2017, of which 49 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Fastener, Fixation, Nondegradable, Soft Tissue, Rod, Fixation, Intramedullary And Accessories, Prosthesis, Ankle, Semi-constrained, Cemented, Metal/polymer, Appliance, Fixation, Nail/blade/plate Combination, Multiple Component, Screw, Fixation, Bone . Use the specialty filter in the sidebar to narrow results.

49 devices
1–25 of 49
Phantom? Hindfoot TTC/TC Nail System
K253591 · HSB Rod, Fixation,... · Orthopedic
Mar 2026 108d
Monkey Rings External Ring Fixation System
K253613 · KTT Appliance, Fixation,... · Orthopedic
Dec 2025 31d
External Fixation Mini Rail System
K252106 · KTT Appliance, Fixation,... · Orthopedic
Sep 2025 89d
External Fixation Bone Distractor
K251862 · KTT Appliance, Fixation,... · Orthopedic
Aug 2025 55d
Baby Gorilla?/Gorilla? Plating System
K250952 · HRS Plate, Fixation, Bone · Orthopedic
Jul 2025 112d
Phantom? Hindfoot TTC/TC Nail System
K251850 · HSB Rod, Fixation,... · Orthopedic
Jul 2025 28d
APEX 3D Total Ankle Replacement System
K250641 · HSN Prosthesis, Ankle,... · Orthopedic
May 2025 58d
Monkey Bars Pin to Bar External Fixation System
K242452 · KTT Appliance, Fixation,... · Orthopedic
Nov 2024 74d
Phantom Fibula Nail System
K234128 · HSB Rod, Fixation,... · Orthopedic
Aug 2024 238d
Grappler Interference Screw System
K241864 · MBI Fastener, Fixation,... · Orthopedic
Jul 2024 28d
APEX 3D Total Ankle Replacement System
K240259 · HSN Prosthesis, Ankle,... · Orthopedic
Jun 2024 145d
Baby Gorilla/Gorilla Plating System; Monster Screw System
K241262 · HRS Plate, Fixation, Bone · Orthopedic
Jun 2024 30d
Grappler Suture Anchor R3FLEX IOL System
K240594 · MBI Fastener, Fixation,... · Orthopedic
Mar 2024 22d
MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation Devices
K231231 · HWC Screw, Fixation, Bone · Orthopedic
Oct 2023 167d
Monkey RingsTM External Fixation System
K232838 · KTT Appliance, Fixation,... · Orthopedic
Oct 2023 28d
TITAN 3-D Wedge System
K231496 · PLF Bone Wedge · Orthopedic
Aug 2023 90d
Grappler Suture Anchor System
K231867 · MBI Fastener, Fixation,... · Orthopedic
Aug 2023 56d
JAWS Nitinol Staple System
K230550 · JDR Staple, Fixation, Bone · Orthopedic
May 2023 72d
Grappler Suture Anchor R3FLEX IOL System
K223589 · MBI Fastener, Fixation,... · Orthopedic
Mar 2023 92d
JAWS Nitinol Staple System
K223056 · JDR Staple, Fixation, Bone · Orthopedic
Feb 2023 139d
Phantom Metatarsal Shortening System
K223184 · HWC Screw, Fixation, Bone · Orthopedic
Dec 2022 65d
MAVEN? Patient-Specific Instrumentation
K223227 · HSN Prosthesis, Ankle,... · Orthopedic
Nov 2022 30d
Grappler Suture Anchor System
K222091 · MBI Fastener, Fixation,... · Orthopedic
Sep 2022 61d
Baby Gorilla?/Gorilla? Plating System
K222194 · HRS Plate, Fixation, Bone · Orthopedic
Aug 2022 28d
Baby Gorilla/Gorilla Plating System
K221465 · HRS Plate, Fixation, Bone · Orthopedic
Jun 2022 29d
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