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FDA 510(k)

BA310 Abutment, BIA310 Implant/Abutment

K-Number: K182116 · 2018-12-19

ApplicantCochlear Americas
Decision Date2018-12-19
Product CodeMAH
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

BA310 Abutment, BIA310 Implant/Abutment is a medical device manufactured by Cochlear Americas. It received FDA 510(k) clearance on 2018-12-19 under approval number K182116. The device is classified under product code MAH. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BA310 Abutment, BIA310 Implant/Abutment?

BA310 Abutment, BIA310 Implant/Abutment is a medical device that received FDA 510(k) clearance on 2018-12-19. It is manufactured by Cochlear Americas. The 510(k) number is K182116.

When was BA310 Abutment, BIA310 Implant/Abutment approved by the FDA?

BA310 Abutment, BIA310 Implant/Abutment received FDA 510(k) clearance on 2018-12-19, under approval number K182116.

What company makes BA310 Abutment, BIA310 Implant/Abutment?

BA310 Abutment, BIA310 Implant/Abutment is manufactured by Cochlear Americas.

What is the FDA product code for BA310 Abutment, BIA310 Implant/Abutment?

The FDA product code for BA310 Abutment, BIA310 Implant/Abutment is MAH.

Related Clinical Trials

NCT07246499 Multicentre Study on the Impact of Transmucosal Abutment Surface Characteristics on Peri-implant Tissues. ACTIVE_NOT_RECRUITING NCT05883202 Effect of the Abutment-Prosthesis Connection on Marginal Bone Loss and Gingival Sealing Around Dental Implants SUSPENDED NCT06636136 Transtibial Osseointegration RECRUITING

Other Devices by Cochlear Americas

K161123Baha 5 Power Sound Processor K153245Baha 5 Super Power Sound Processor K171088Cochlear Baha SoundArc K191921Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Osia Fitting Software 2.0, Osia SmartApp, Cochlear Osia Surgical Instruments K190589Cochlear Osia OSI100 Implant, Cochlear Osia Sound Processor, Osia Intraoperative Test Software, Osia Fitting Software, Cochlear Osia Surgical Instruments K212136Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha Smart App

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Related Devices (Code: MAH)

K152820Ponto Bone Anchored Hearing SystemOticon Medical AB K203807Ponto Bone Anchored Hearing System, MONO Surgery KitOticon Medical AB

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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