FDA.reportPublic FDA data

Fixture ST 4mm

Primary DI
09321502014328
Brand
Fixture ST 4mm
Company
Cochlear Bone Anchored Solutions AB
Model
90440
Catalog number
90440
Device description
Fixture ST 4mm
Published
2015-10-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FZEPROSTHESIS, NOSE, INTERNAL
LXBHearing aid, bone conduction

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZEProsthesis, Nose, InternalGeneral, Plastic Surgery2
LXBHearing Aid, Bone ConductionEar, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K945154000
K955713000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K945154000BA-CPASNobelpharma USA, Inc.1995-01-13FZE
K955713000NOBELPHARMA BONE ANCHORED HEARING AIDNobelpharma USA, Inc.1996-08-09LXB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09321502014328PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09321502014328093215020143289321502014328

GMDN Terms#

Term, Definition table
TermDefinition
Craniofacial bone screw, non-bioabsorbableA small, threaded rod with a slotted head intended to be implanted in craniofacial bone (including the maxilla and/or mandible) for fracture fixation by direct interfragmentary stabilization of bone or by screwing plates in place; it may also be intended for transplanted bone fixation. It may be self-drilling/self-tapping and is made of a material that is not chemically degraded or absorbed via natural body processes [e.g., implant grade metal such as titanium (Ti)]. Its uses include repair of orbital fractures and fractures around the cranial sinuses, paediatric reconstructive surgery, craniotomy flap fixation, bone augmentation procedures.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length4Millimeter

Sterilization Methods#

Method table
Method
Radiation Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)523-5798customer@cochlear.com

Regulatory Flags#

DUNS number
559784736
Device count
1
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09321502019613Baha92140921402015-10-09
09321502019620Baha92141921412015-10-09
09321502025157Baha93339933392017-06-07
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09321502045025Baha IndicatorP1582203P15822032023-05-15
09321502045032Abutment InserterP1582229P15822292023-05-15
09321502045049Implant InserterP1582230P15822302023-05-15
09321502045056Counter Torque WrenchP1582231P15822312023-05-15
09321502046312Raspatorium/ProbeP1593725P15937252023-05-15
09321502021746Counter torque wrench for Vistafix® VXA30093183931832017-06-07
09321502027090Soft tissue gauge 6 mm95070950702017-06-07
09321502036351BahaP806653P8066532017-06-07
09321502036368BahaP806693P8066932017-06-07
09321502040105Baha90238902382017-06-07
09321502015912Baha90623906232017-07-03
09321502016032Baha90627906272017-07-03
09321502020657Baha90068900682017-07-03
09321502040051Baha90625906252017-07-03
09321502040068Baha90629906292017-07-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09120041056673contact forte AlphaBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-04-17
09120041056697contact forte AlphaBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-04-17
09120041056703contact forte AlphaBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-04-17
09120041056710contact forte AlphaBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-04-17
09120041056727contact forte AlphaBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-04-17
09120041056734contact forteBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-04-17
09120041056741contact forteBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-04-17
09120041056758contact forteBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-04-17
09120041056765contact forteBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-04-17
09120041056772contact forteBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-04-17
09120041056895HearbowBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-04-17
09321502052122Cochlear™ Baha® 6 Max Battery Door, Tamper ResistantCochlear Bone Anchored Solutions ABLXB2021-02-25
09321502053051Cochlear™ Baha® 6 Max Battery Door, 10 pcsCochlear Bone Anchored Solutions ABLXB2021-02-25
09321502053068Cochlear™ Baha® 6 Max Battery Door, 3 pcsCochlear Bone Anchored Solutions ABLXB2021-02-25
09321502021319BahaCochlear Bone Anchored Solutions ABLXB2017-07-03
09321502021326BahaCochlear Bone Anchored Solutions ABLXB2017-07-03
09321502021333BahaCochlear Bone Anchored Solutions ABLXB2017-07-03
09321502021340BahaCochlear Bone Anchored Solutions ABLXB2017-07-03
09321502021357BahaCochlear Bone Anchored Solutions ABLXB2017-07-03
09321502021364BahaCochlear Bone Anchored Solutions ABLXB2017-07-03
09321502026383BahaCochlear Bone Anchored Solutions ABLXB2017-07-03
09321502032834BahaCochlear Bone Anchored Solutions ABLXB2017-07-03
09321502036023BahaCochlear Bone Anchored Solutions ABLXB2017-07-03
09321502013932BahaCochlear Bone Anchored Solutions ABLXB2017-06-07
09321502015554BahaCochlear Bone Anchored Solutions ABLXB2017-06-07
09321502015615BahaCochlear Bone Anchored Solutions ABFZE2017-06-07
09321502016513BahaCochlear Bone Anchored Solutions ABLXB2017-06-07
09321502019675BahaCochlear Bone Anchored Solutions ABLXB2017-06-07
09321502020725BahaCochlear Bone Anchored Solutions ABLXB2017-06-07
09321502020732BahaCochlear Bone Anchored Solutions ABFZE2017-06-07