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 a medical device manufactured by Intrauma S.P.A. It received FDA 510(k) clearance on 2023-09-01 under approval 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. It is manufactured by Intrauma S.P.A. The 510(k) number is K230623.
When was KITE Distal Fibula Kit approved by the FDA?
KITE Distal Fibula Kit received FDA 510(k) clearance on 2023-09-01, under approval number K230623.
What company makes KITE Distal Fibula Kit?
KITE Distal Fibula Kit is manufactured by Intrauma S.P.A.
What is the FDA product code for KITE Distal Fibula Kit?
The FDA product code for KITE Distal Fibula Kit is HRS.
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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.