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FDA 510(k)

Guided DAS Surgical Kit

K-Number: K243425 · 2025-07-22

ApplicantTalladium España, SL
Decision Date2025-07-22
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Guided DAS Surgical Kit is a medical device manufactured by Talladium España, SL. It received FDA 510(k) clearance on 2025-07-22 under approval number K243425. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Guided DAS Surgical Kit?

Guided DAS Surgical Kit is a medical device that received FDA 510(k) clearance on 2025-07-22. It is manufactured by Talladium España, SL. The 510(k) number is K243425.

When was Guided DAS Surgical Kit approved by the FDA?

Guided DAS Surgical Kit received FDA 510(k) clearance on 2025-07-22, under approval number K243425.

What company makes Guided DAS Surgical Kit?

Guided DAS Surgical Kit is manufactured by Talladium España, SL.

What is the FDA product code for Guided DAS Surgical Kit?

The FDA product code for Guided DAS Surgical Kit is KCT.

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Related PubMed Literature

PMID: 42184430 Navigation-guided endoscopic transcerebellar approach for cyst fenestration of a dorsal brainstem lesion: illustrative case. Journal of neurosurgery. Case lessons (2026)

Other Devices by Talladium España, SL

K212108Dynamic TiBase K231559Multi-Unit DAS System K232151Dynamic TiBase K241170Dynamic TiBase; TRI Screws K243530Dynamic TiBase K243732Multi-Unit DAS System

View all 7 devices →

Related Devices (Code: KCT)

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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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