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Novastep SAS

France · Rennes Bretagne

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Taiwan, Singapore, Australia, Israel — 6 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

8listed device types

Class I 4Class II 4Class III 0

plus 14 registration records and 9 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

2registered devices

Class I 1Class II 1

11 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

3valid device licences

Class I 1Class II 2

SGSingaporeHSA SMDR

3device registrations

CLASS B 1CLASS C 2

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

11active ARTG entries

Class I 2IIa 4IIb 5

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

4registrations

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 States14 registration records, 9 510(k), 0 PMA

Brazil2 confirmed, 0 excluded

Manufacturer names merged into this page: NOVASTEP · NOVASTEP S.A.S

FDA 510(k) clearances by year

52015 · K151277

12019 · K192356

22023 · K230724

12026 · K260274

FDA listed device types

Pin, Fixation, Smooth 1Screw, Fixation, Bone 1Staple, Fixation, Bone 1Plate, Fixation, Bone 1Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment 1Guide, Surgical, Instrument 1Tray, Surgical, Instrument 1Orthopedic Manual Surgical Instrument 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K260274	Airlock® Ankle Plating System	2026-03-25
US	K230724	arcad® 2.0 Duo & Quadro osteosynthesis compressive staples	2023-12-04
US	K223468	Nexis® compressive screws	2023-08-30
BR	80102519220	INSTRUMENTAIS ESTÉREIS NOVASTEP	Class II
BR	80102513200	INSTRUMENTAIS NÃO-ESTÉREIS NOVASTEP	Class I

Novastep SAS

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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