Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9616024

FEI Number

3003222064

Entity Name

COCHLEAR BONE ANCHORED SOLUTIONS AB

City/State/Country

Molnlycke Vastra Gotaland, SE

Establishment Address

Konstruktionsvagen 14, Molnlycke Vastra Gotaland SE-435 33, SE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

COCHLEAR AMERICAS (Owner Number: 9076254)

Owner / Operator Contact Address

10350 Park Meadows Drive, Lone Tree, CO 80124, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K250215

PMA Number

N/A

All Registered Proprietary Names

Instrument Case (Phase 2) Osia 2 System Osia 2 System Ba400 14mm Abutment Osscora Surgical Set Baha Vistafix ENT Surgical Instrument Case Baha BIA300 Implants with Abutments SoundArc Headband for Baha Baha Attract Baha BA400 Abutment BA310 Abutment, BIA310 Implant/Abutment Baha 6 Max Sound Processor Baha Smart App Baha Fitting Software 6 BAHA IMPLANT SYSTEM Baha 5 SuperPower Sound Processor Baha 5 Power Cochlear Baha 7 System Baha Smart App Baha 7 Sound Processor and Accessories Cochlear SoundBand Baha Fitting Software 7

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MAH	Hearing Aid, Bone Conduction, Implanted	Ear, Nose, Throat	Class 2	874.3302	2023-09-13
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2023-09-13
PFO	Active Implantable Bone Conduction Hearing System	Ear, Nose, Throat	Class 2	874.3340	2023-09-13
PFO	Active Implantable Bone Conduction Hearing System	Ear, Nose, Throat	Class 2	874.3340	2022-07-29
PFO	Active Implantable Bone Conduction Hearing System	Ear, Nose, Throat	Class 2	874.3340	2019-11-19
MAH	Hearing Aid, Bone Conduction, Implanted	Ear, Nose, Throat	Class 2	874.3302	2015-07-23
GEY	Motor, Surgical Instrument, Ac-Powered	General, Plastic Surgery	Class 1	878.4820	2003-03-07
FZE	Prosthesis, Nose, Internal	General, Plastic Surgery	Class 2	878.3680	2003-03-18
LRC	Instrument, Ent Manual Surgical	Ear, Nose, Throat	Class 1	874.4420	2012-05-29
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2023-09-13
LXB	Hearing Aid, Bone Conduction	Ear, Nose, Throat	Class 2	874.3302	2010-10-06
LXB	Hearing Aid, Bone Conduction	Ear, Nose, Throat	Class 2	874.3302	2017-06-23
LXB	Hearing Aid, Bone Conduction	Ear, Nose, Throat	Class 2	874.3302	2008-10-23
LXB	Hearing Aid, Bone Conduction	Ear, Nose, Throat	Class 2	874.3302	2013-11-18
MAH	Hearing Aid, Bone Conduction, Implanted	Ear, Nose, Throat	Class 2	874.3302	2012-11-19
MAH	Hearing Aid, Bone Conduction, Implanted	Ear, Nose, Throat	Class 2	874.3302	2019-04-04
LXB	Hearing Aid, Bone Conduction	Ear, Nose, Throat	Class 2	874.3302	2021-02-23
LXB	Hearing Aid, Bone Conduction	Ear, Nose, Throat	Class 2	874.3302	2005-08-11
LXB	Hearing Aid, Bone Conduction	Ear, Nose, Throat	Class 2	874.3302	2016-03-02
LXB	Hearing Aid, Bone Conduction	Ear, Nose, Throat	Class 2	874.3302	2016-05-31
LXB	Hearing Aid, Bone Conduction	Ear, Nose, Throat	Class 2	874.3302	2025-06-02

Official Correspondent

No official correspondent registered.

US Agent Details

Laura Blair Business: Cochlear Americas Email: lblair@cochlear.com Phone: (800) 5235798

Related Public Records

Same Entity

COCHLEAR AMERICAS

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3002806740	COCHLEAR LTD.	LANE COVE New South Wales, AU
3013177549	Cochlear Malaysia Sdn Bhd	Kuala Lumpur Kuala Lumpur, MY
3009092818	Cochlear Ltd	Macquarie University New South Wales, AU
9613646	Cochlear Limited - Brisbane	Newstead Queensland, AU
3014579188	Cochlear Americas Warehouse	Centennial, CO, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K243425	Talladium España, SL	Guided DAS Surgical Kit	2025-07-22
K213209	K1 Medical, LLC	EZ-TRAX Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device	2021-12-28
K012105	Symmetry Medical, Inc.	POLYVAC SURGICAL INSTRUMENT DELIVERY SYSTEM	2002-08-02
K243317	Infinitum Eta, Ltd.	NUVENTUS NV.C Surgical Cassette and Tray	2025-02-11
K112536	Covidien	SONICISION STERILIZATION TRAY	2012-04-19

Similar Registrations

Registration Number	Establishment Name	Location
3009307953	Demant Operations Poland Sp. z o.o.	Mierzyn Zachodniopomorskie, PL
3005900820	COCHLEAR AMERICAS	Lone Tree, CO, US
3007367732	Oticon Medical AB	Askim Vastra Gotaland, SE
3003847101	ELOS MEDTECH TIMMERSDALA AB	TIMMERSDALA Vastra Gotaland, SE
3007051929	MEDICAL GROUP	SAINT-PRIEST Auvergne-Rhone-Alpes, FR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9616024. Last updated year: 2026. Please use registration number 9616024 when referencing this establishment in official correspondence.