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ORTHONOVIS, INC.

USA · Palm Coast

✓ Record-verifiedregistrations found in 1 markets

This company has registrations in United States — 1 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

12listed device types

Class I 1Class II 10Class III 0unclassified 1

plus 15 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

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

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 States15 registration records, 5 510(k), 0 PMA

Manufacturer names merged into this page: ORTHONOVIS, INC.

FDA 510(k) clearances by year

12022 · K213905

12024 · K242343

32025 · K252758

FDA listed device types

showing 8 of 12

Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component 1Filler, Bone Void, Calcium Compound 1Rod, Fixation, Intramedullary And Accessories 1Staple, Fixation, Bone 1Pin, Fixation, Smooth 1Nail, Fixation, Bone 1Plate, Fixation, Bone 1Screw, Fixation, Bone 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K252758	Cannulated Screw and Kirschner (K wire) System	2025-10-02
US	K250498	BPS Wrist Fracture System	2025-03-17
US	K250055	BPS - Bone Fragment Fixation Plates, Screws and Washers	2025-02-06

ORTHONOVIS, 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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