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ICONN ORTHOPEDICS, LLC

USA · Birmingham

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Taiwan, Israel — 3 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

7listed device types

Class I 5Class II 2Class III 0

plus 9 registration records and 5 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

1valid device licences

Class II 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

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 States9 registration records, 5 510(k), 0 PMA

Manufacturer names merged into this page: ICONN ORTHOPEDICS, LLC

FDA 510(k) clearances by year

12014 · K132724

12017 · K172491

32018 · K180670

FDA listed device types

Screw, Fixation, Bone 1Fastener, Fixation, Nondegradable, Soft Tissue 1Brace, Drill 1Screwdriver 1Tap, Bone 1Tray, Surgical, Instrument 1Orthopedic Manual Surgical Instrument 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K180670	ICONN Campbell Interference Screw	2018-12-07
US	K182264	ICONN Revolution Knotless Suture Anchor	2018-10-19
US	K181680	ICONN Answer II Suture Anchor	2018-08-09

ICONN ORTHOPEDICS, LLC

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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