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Paragon 28, Inc.

USA · Englewood

✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Canada, Singapore, Australia, Hong Kong, Israel — 7 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

51listed device types

Class I 32Class II 18Class III 0unclassified 1

plus 90 registration records and 59 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

2registered devices

Class I 2

6 including historic records

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

20 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

5device registrations

CLASS C 5

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

51active ARTG entries

Class I 15IIa 11IIb 24Class Im (measuring) 1

HKHong KongMDACS

1valid listings

Class III 1

ILIsraelAMAR

2registrations

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States90 registration records, 59 510(k), 0 PMA

Brazil2 confirmed, 0 excluded

Manufacturer names merged into this page: PARAGON 28 · PARAGON 28, INC.

FDA 510(k) clearances by year

12014

22015

42017

22018

72019

72020

82021

52022

72023

62024

62025

42026

FDA listed device types

showing 8 of 51

Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component 1Filler, Bone Void, Calcium Compound 1Ankle Arthroplasty Implantation System 1Rod, Fixation, Intramedullary And Accessories 1Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) 1Staple, Fixation, Bone 1Pin, Fixation, Smooth 1Appliance, Fixation, Nail/Blade/Plate Combination, Single Component 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K261121	Megalodon Dynamic Compression System	2026-08-06
US	K262047	Grappler Suture Anchor System	2026-08-03
US	K253886	Grappler Suture Anchor PCFD Tether System	2026-03-17
BR	80102513223	INSTRUMENTAIS MONSTER®	Class I
BR	80102513224	INSTRUMENTAIS GORILLA®	Class I

Paragon 28, Inc.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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