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BONE SOLUTIONS, INC.

USA · Colleyville

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Singapore — 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

13listed device types

Class I 3Class II 10Class III 0

plus 29 registration records and 8 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

6registered devices

Class I 1Class II 5

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

73registered imported devices

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

CACanadaMDALL

7active device licences

Class II 6Class III 1

18 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

1device registrations

CLASS D 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

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 States29 registration records, 8 510(k), 0 PMA, 16 excluded

Brazil6 confirmed, 10 excluded

Saudi Arabia73 confirmed, 4 excluded

Canada7 confirmed, 2 excluded

Manufacturer names merged into this page: BONE SOLUTIONS, INC. · COCHLEAR BONE ANCHORED SOLUTIONS AB · Cochlear Bone Anchord Solutions AB

FDA 510(k) clearances by year

12009 · K071004

12016 · K161568

12020 · K192674

22022 · K221256

22024 · K242372

12025 · K251522

FDA listed device types

showing 8 of 13

Filler, Bone Void, Calcium Compound 1Active Implantable Bone Conduction Hearing System 1Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) 1Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation 1Syringe, Piston 1Hearing Aid, Bone Conduction 1Prosthesis, Nose, Internal 1Hearing Aid, Air-Conduction With Wireless Technology, Prescription 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K251522	Mg OSTEOINJECT; Mg OSTEOREVIVE; Mg OSTEOCRETE	2025-10-13
US	K242372	Mg OSTEOREVIVE, Mg OSTEOCRETE	2024-10-18
US	K234013	Mg OSTEOINJECT; Mg OSTEOREVIVE; Mg OSTEOCRETE	2024-02-05
BR	10178010293	PROCESSADOR BAHA 5 SUPER POWER	Class II
BR	10178010285	Kit Instrumental Reusável BAHA Attract	Class I
BR	10178010232	BROCA CIRÚRGICA DESCARTÁVEL BAHA	Class II
SA	ME0000001654SFDAA00031	SP Magnet 2	—
SA	ME0000001654SFDAA00071	Cochlear Baha Remote Control 2, EU	—
CA	64754	BAHA DERMATOME	Class II
CA	65166	BAHA BLADE	Class II
CA	67547	BAHA DIVINO DIGITAL IMPLANTABLE HEARING AID	Class III

BONE SOLUTIONS, 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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