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Isotis Orthobiologics, Inc.

USA · Irvine

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Canada, Singapore, South Korea, Hong Kong, 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

4listed device types

Class I 0Class II 4Class III 0

plus 23 registration records and 10 510(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

2active device licences

Class III 2

7 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

2device registrations

CLASS D 2

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

1valid listings

Class IV 1

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 States23 registration records, 10 510(k), 0 PMA

Canada2 confirmed, 0 excluded

Manufacturer names merged into this page: ISOTIS ORTHOBIOLOGICS, INC · ISOTIS ORTHOBIOLOGICS, INC.

FDA 510(k) clearances by year

22004

52005 · K050642

12007 · K070751

12008 · K081817

12009 · K091193

FDA listed device types

Orthopedic Stereotaxic Instrument 1Filler, Bone Void, Calcium Compound 1Bone Grafting Material, Human Source 1Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K091193	ACCELL EVO3C	2009-08-10
US	K081817	ACCELL TBM-R	2008-09-24
US	K070751	ORTHOBLAST II DBM DEMINERALIZED BONE MATRIX PASTE AND PUTTY	2007-10-15
CA	66219	OSSATURA DENTAL	Class III
CA	66255	OSSATURA BCP	Class III

Isotis Orthobiologics, 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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