FDA 510(k)

FIX-C 3D Ti ACIF System

K-Number: K243915 · 2025-02-18

Decision Date2025-02-18

Product CodeODP

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

FIX-C 3D Ti ACIF System is a medical device manufactured by Jeil Medical Corporation. It received FDA 510(k) clearance on 2025-02-18 under approval 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. It is manufactured by Jeil Medical Corporation. The 510(k) number is K243915.

When was FIX-C 3D Ti ACIF System approved by the FDA?

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

What company makes FIX-C 3D Ti ACIF System?

FIX-C 3D Ti ACIF System is manufactured by Jeil Medical Corporation.

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.

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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.