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FDA 510(k)

KITE Distal Fibula Kit

K-Number: K230623 · 2023-09-01

ApplicantIntrauma S.P.A
Decision Date2023-09-01
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

KITE Distal Fibula Kit is the device name listed in this FDA 510(k) record. The listed applicant is Intrauma S.P.A. It received FDA 510(k) clearance on 2023-09-01 under 510(k) number K230623. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KITE Distal Fibula Kit?

KITE Distal Fibula Kit is a medical device that received FDA 510(k) clearance on 2023-09-01. The listed applicant is Intrauma S.P.A. The 510(k) number is K230623.

When did KITE Distal Fibula Kit receive FDA 510(k) clearance?

KITE Distal Fibula Kit received FDA 510(k) clearance on 2023-09-01, under 510(k) number K230623.

Who is the listed applicant for KITE Distal Fibula Kit?

The FDA 510(k) record lists Intrauma S.P.A as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KITE Distal Fibula Kit?

The FDA product code for KITE Distal Fibula Kit is HRS.

Other records listing Intrauma S.P.A as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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