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FDA 510(k)

FIX-C 3D Ti ACIF System

K-Number: K243915 · 2025-02-18

ApplicantJeil Medical Corporation
Decision Date2025-02-18
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

FIX-C 3D Ti ACIF System is the device name listed in this FDA 510(k) record. The listed applicant is Jeil Medical Corporation. It received FDA 510(k) clearance on 2025-02-18 under 510(k) number K243915. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FIX-C 3D Ti ACIF System?

FIX-C 3D Ti ACIF System is a medical device that received FDA 510(k) clearance on 2025-02-18. The listed applicant is Jeil Medical Corporation. The 510(k) number is K243915.

When did FIX-C 3D Ti ACIF System receive FDA 510(k) clearance?

FIX-C 3D Ti ACIF System received FDA 510(k) clearance on 2025-02-18, under 510(k) number K243915.

Who is the listed applicant for FIX-C 3D Ti ACIF System?

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

What is the FDA product code for FIX-C 3D Ti ACIF System?

The FDA product code for FIX-C 3D Ti ACIF System is ODP.

Other records listing Jeil Medical Corporation as applicant

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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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