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FDA 510(k)

DIO UF HSA INTERNAL SUB-MERGED IMPLANT SYSTEM

K-Number: K122519 · 2013-05-21

ApplicantDio Corporation
Decision Date2013-05-21
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DIO UF HSA INTERNAL SUB-MERGED IMPLANT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Dio Corporation. It received FDA 510(k) clearance on 2013-05-21 under 510(k) number K122519. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIO UF HSA INTERNAL SUB-MERGED IMPLANT SYSTEM?

DIO UF HSA INTERNAL SUB-MERGED IMPLANT SYSTEM is a medical device that received FDA 510(k) clearance on 2013-05-21. The listed applicant is Dio Corporation. The 510(k) number is K122519.

When did DIO UF HSA INTERNAL SUB-MERGED IMPLANT SYSTEM receive FDA 510(k) clearance?

DIO UF HSA INTERNAL SUB-MERGED IMPLANT SYSTEM received FDA 510(k) clearance on 2013-05-21, under 510(k) number K122519.

Who is the listed applicant for DIO UF HSA INTERNAL SUB-MERGED IMPLANT SYSTEM?

The FDA 510(k) record lists Dio Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DIO UF HSA INTERNAL SUB-MERGED IMPLANT SYSTEM?

The FDA product code for DIO UF HSA INTERNAL SUB-MERGED IMPLANT SYSTEM is DZE.

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Related Devices (Code: DZE)

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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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