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NOVABONE PRODUCTS, LLC

USA · Alachua

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Canada, Taiwan, 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

6listed device types

Class I 3Class II 2Class III 0unclassified 1

plus 19 registration records and 30 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

1registered devices

Class I 1

8 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

3active device licences

Class III 3

11 including historic records

TWTaiwanTFDA

2valid device licences

Class II 2

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

6active ARTG entries

Class I 1Class III 5

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

3registrations

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 States19 registration records, 30 510(k), 0 PMA

Brazil1 confirmed, 0 excluded

Canada3 confirmed, 0 excluded

Manufacturer names merged into this page: NOVABONE PRODUCTS, LLC · NOVABONE PRODUCTS LLC · NOVABONE PRODUCTS,LLC

FDA 510(k) clearances by year

12002

12003

32004

12005

42006

22007

22008

22009

22010

42011

22014

22015

12017

12023

22024

FDA listed device types

Orthopedic Manual Surgical Instrument 1Syringe, Restorative And Impression Material 1Tamp 1Filler, Bone Void, Calcium Compound 1Bone Grafting Material, Synthetic 1Wound Dressing With Animal-Derived Material(S) 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K242299	NovaBone Putty - Synthetic Bioactive Bone Graft	2024-09-25
US	K240404	NovaBone Putty - Bioactive Synthetic Bone Graft (NB6600, NB6610, NB6615)	2024-03-05
US	K220498	NovoGen Wound Matrix	2023-06-09
BR	80117580767	Dental Putty Cartridge Dispenser	Class I
CA	12502	ERMI (BIOGLASS ENDOSSEOUS RIDGE MAINTENANCE IMPLANT)	Class III
CA	64132	NOVABONE-C/M - SYNTHETIC BONE GRAFT PARTICULATE	Class III
CA	65814	NOVABONE-OM - RESORBABLE BONE GRAFT SUBSTITUTE	Class III

NOVABONE PRODUCTS, 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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