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OSTEOTECH, INC.

USA · Eatontown

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Canada, Taiwan, South Korea, Australia — 5 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 9 registration records and 24 510(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 1Class IV 1

TWTaiwanTFDA

2valid device licences

Class II 2

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

1active ARTG entries

Class I 1

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 States9 registration records, 24 510(k), 0 PMA

Canada2 confirmed, 0 excluded

Manufacturer names merged into this page: OSTEOTECH, INC. · OSTEOTECH INC

FDA 510(k) clearances by year

11985

11988

21995

11996

11997

11998

21999

12000

22001

62005

12006

12007

42008

FDA listed device types

Filler, Bone Void, Calcium Compound 1Bone Grafting Material, Human Source 1Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) 1Syringe, Piston 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K082615	GRAFTON R II EDBM, DEMINERALIZED BONE MATRIX ALLOGRAFT, RESORBABLE CALCIUM SALT BONE VOID FILLER DEVICES	2008-10-16
US	K081227	PLEXUR M	2008-07-22
US	K080511	PLEXUR-P	2008-04-21
CA	32089	VERTEBRAL BODY REPLACEMENT (VBR)	Class III
CA	33675	DEMINERALIZED BONE MATRIX/FIBER	Class IV

OSTEOTECH, 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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