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510(k) K121228

Device
PONTO BONE ANCHORED HEARING SYSTEM
Applicant
OTICON MEDICAL AB
510(k) number
K121228
Product code
MAH  
Decision
Substantially Equivalent (SESE)
Decision date
2012-09-07
Date received
2012-04-23
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
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
KAROLIN ISBERG JERNBY
Address
Ekonomivagen 2 Askim SE SE-436 33 SE-436 33

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
K203807Ponto Bone Anchored Hearing System, MONO Surgery KitOticon Medical AB2021-03-03
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
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#

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