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FDA 510(k)

OFIX MIS App

K-Number: K230252 · 2023-09-26

ApplicantOrthofix US, LLC
Decision Date2023-09-26
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

OFIX MIS App is the device name listed in this FDA 510(k) record. The listed applicant is Orthofix US, LLC. It received FDA 510(k) clearance on 2023-09-26 under 510(k) number K230252. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OFIX MIS App?

OFIX MIS App is a medical device that received FDA 510(k) clearance on 2023-09-26. The listed applicant is Orthofix US, LLC. The 510(k) number is K230252.

When did OFIX MIS App receive FDA 510(k) clearance?

OFIX MIS App received FDA 510(k) clearance on 2023-09-26, under 510(k) number K230252.

Who is the listed applicant for OFIX MIS App?

The FDA 510(k) record lists Orthofix US, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OFIX MIS App?

The FDA product code for OFIX MIS App is LLZ.

Other records listing Orthofix US, LLC as applicant

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Official Source

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

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