FDA.reportPublic FDA data

510(k) K203807

Device
Ponto Bone Anchored Hearing System, MONO Surgery Kit
Applicant
Oticon Medical AB
510(k) number
K203807
Product code
MAH  
Decision
Substantially Equivalent (SESE)
Decision date
2021-03-03
Date received
2020-12-28
Regulation
874.3300
Classification name
Hearing Aid, Bone Conduction, Implanted
Medical specialty
Ear Nose & Throat
Review panel
Ear Nose & Throat
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Carolina Anker Wessling
Address
Datavagen 37b Askim SE SE-436 32 SE-436 32

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MAH  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K182116BA310 Abutment, BIA310 Implant/AbutmentCochlear Americas2018-12-19
K152820Ponto Bone Anchored Hearing SystemOticon Medical AB2016-01-22
K152067Ponto bone anchored hearing systemOticon Medical AB2015-11-23
K150555BA400 14mm AbutmentCochlear Americas2015-07-15
K142678Ponto Bone Anchored Hearing system/ Abutment, 14mm. Ponto Bone Anchored Hearing System / Wide implant, 4mm, with abutment, 14 mmOticon Medical AB2015-01-21
K121317COCHLEAR BAHA IMPLANT SYSTEMCochlear Americas2012-10-12
K121228PONTO BONE ANCHORED HEARING SYSTEMOticon Medical AB2012-09-07
K112053OBC BONE ANCHORED HEARING SYSTEMOticon Medical AB2011-11-18
K080363BAHA CORDELLE IICochlear Bone Anchored Systems AB2008-04-10
K984162BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM FOR PEDIATRIC USENobelpharma USA, Inc.1999-06-28

Legacy Summary#

summary

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases