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BIOPLATE, INC.

USA · Los Angeles

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Australia, Russia — 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

10listed device types

Class I 5Class II 5Class III 0

plus 17 registration records and 23 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

1registered devices

Class I 1

3 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

1active device licences

Class II 1

9 including historic records

TWTaiwanTFDA

2valid device licences

Class II 2

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

4active ARTG entries

Class I 1IIb 3

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

1active registrations

Class 2b 1

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 States17 registration records, 23 510(k), 0 PMA

Brazil1 confirmed, 0 excluded

Canada1 confirmed, 1 excluded

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

FDA 510(k) clearances by year

22000

72001

72002

22003

12005

12006

12007

22008

FDA listed device types

showing 8 of 10

Filler, Bone Void, Calcium Compound 1Plate, Bone 1Plate, Fixation, Bone 1Plate, Cranioplasty, Preformed, Non-Alterable 1Cover, Burr Hole 1Instrument, Bending Or Contouring 1Forceps 1Screwdriver, Surgical 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K082757	MODIFIED STERILE PLATE & SCREW KIT CONFIGURATIONS FOR USE WITH BIOPLATE TITANIUM FIXATION SYSTEM	2008-10-01
US	K082175	MOFICATION TO: MODIFIED PLATE DESIGN FOR BIOPLATE ZIP CRANIOTOMY FIXATION	2008-08-13
US	K070901	MODIFIED PLATE DESIGN FOR BIOPLATE ZIP CRANIOTOMY FIXATION SYSTEM	2007-06-15
BR	10364310013	INSTRUMENTAL PARA O SISTEMA PARA FIXACAO OSSEA RIGIDA BIOPLATE	Class I
CA	28295	BIOPLATE BATTERY POWERED SCREWDRIVER	Class II

BIOPLATE, 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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