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 a medical device manufactured by Orthofix US, LLC. It received FDA 510(k) clearance on 2023-09-26 under approval 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. It is manufactured by Orthofix US, LLC. The 510(k) number is K230252.
When was OFIX MIS App approved by the FDA?
OFIX MIS App received FDA 510(k) clearance on 2023-09-26, under approval number K230252.
What company makes OFIX MIS App?
OFIX MIS App is manufactured by Orthofix US, LLC.
What is the FDA product code for OFIX MIS App?
The FDA product code for OFIX MIS App is LLZ.
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PMA P210035Stimulator, bone growth, non-invasive
Related Devices (Code: LLZ)
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.