FDA.reportPublic FDA data

Ponto

Primary DI
05712149009619
Brand
Ponto
Company
Oticon Medical AB
Model
M52169
Catalog number
M52169
Device description
Ponto BHX Implant, 4 mm, with abutment, 9 mm
Published
2015-11-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MAHHearing Aid, Bone Conduction, Implanted

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAHHearing Aid, Bone Conduction, ImplantedEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05712149009619PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05712149009619057121490096195712149009619

GMDN Terms#

Term, Definition table
TermDefinition
Craniofacial bone screw, non-bioabsorbable, sterileA small, sterile, threaded rod with a slotted head intended to be implanted or inserted short-term 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
Length4Millimeter
Length9Millimeter
Outer Diameter4.5Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
888-277-8014info@oticonmedical.com

Regulatory Flags#

DUNS number
554563994
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05712149026562Ponto2276862276862022-09-17
05712149026579Ponto2276872276872022-09-17
05712149026586Ponto2276882276882022-09-17
05712149026593Ponto2276892276892022-09-17
05712149026609Ponto2276902276902022-09-17
05712149026616Ponto2276912276912022-09-17
05712149026623Ponto2276922276922022-09-17
05712149026630Ponto2276932276932022-09-17
05712149026722Ponto2277022277022022-09-17
05712149026739Ponto2277032277032022-09-17
05712149026746Ponto2277042277042022-09-17
05712149026753Ponto2277052277052022-09-17
05712149026760Ponto2277062277062022-09-17
05712149026777Ponto2277072277072022-09-17
05712149026784Ponto2277082277082022-09-17
05712149026791Ponto2277092277092022-09-17
05712149027743Ponto Instant2846482846482026-05-21
05712149027453Ponto2676342676342023-08-21
05712149027460Ponto2676352676352023-08-21
05712149027477Ponto2676362676362023-08-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05712149026494PontoOticon Medical ABMAH2022-04-01
05712149026500PontoOticon Medical ABMAH2022-04-01
05712149026517PontoOticon Medical ABMAH2022-04-01
05712149026524PontoOticon Medical ABMAH2022-04-01
05712149026531PontoOticon Medical ABMAH2022-04-01
05712149026548PontoOticon Medical ABMAH2022-04-01
05712149026555PontoOticon Medical ABMAH2022-04-01
05712149026319PontoOticon Medical ABMAH2021-09-01
05712149026432PontoOticon Medical ABMAH2021-09-01
05712149026449PontoOticon Medical ABMAH2021-09-01
05712149026456PontoOticon Medical ABMAH2021-09-01
05712149026463PontoOticon Medical ABMAH2021-09-01
05712149026470PontoOticon Medical ABMAH2021-09-01
05712149026487PontoOticon Medical ABMAH2021-09-01
05712149026302PontoOticon Medical ABMAH2021-03-31
09321502043847BahaCochlear Bone Anchored Solutions ABMAH2020-01-25
09321502043854BahaCochlear Bone Anchored Solutions ABMAH2020-01-25
09321502043892BIA310 Implant 4mm with 6mm abutmentCochlear Bone Anchored Solutions ABMAH2019-05-22
09321502043908BIA310 Implant 4 mm with 14mm abutmentCochlear Bone Anchored Solutions ABMAH2019-05-22
09321502043861BahaCochlear Bone Anchored Solutions ABMAH2019-05-16
09321502043878BahaCochlear Bone Anchored Solutions ABMAH2019-05-16
09321502043885BahaCochlear Bone Anchored Solutions ABMAH2019-05-16
09321502043915BIA310 Implant 4mm with 12mm abutmentCochlear Bone Anchored Solutions ABMAH2019-05-16
09321502043922BIA310 Implant 4mm with 10mm abutmentCochlear Bone Anchored Solutions ABMAH2019-05-16
09321502043939BIA310 Implant 4mm with 8mm abutmentCochlear Bone Anchored Solutions ABMAH2019-05-16
05712149025091PontoOticon Medical ABMAH2018-10-24
05712149025107PontoOticon Medical ABMAH2018-10-24
05712149000326PontoOticon Medical ABMAH2016-09-16
05712149000562PontoOticon Medical ABMAH2016-09-16
05712149000586PontoOticon Medical ABMAH2016-09-16