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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 the device name listed in this FDA 510(k) record. The listed applicant is Talladium España, SL. It received FDA 510(k) clearance on 2025-07-22 under 510(k) 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. The listed applicant is Talladium España, SL. The 510(k) number is K243425.

When did Guided DAS Surgical Kit receive FDA 510(k) clearance?

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

Who is the listed applicant for Guided DAS Surgical Kit?

The FDA 510(k) record lists Talladium España, SL as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Talladium España, SL 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.

K243732Multi-Unit DAS SystemK243530Dynamic TiBaseK241170Dynamic TiBase; TRI ScrewsK231559Multi-Unit DAS SystemK232151Dynamic TiBaseK212108Dynamic TiBase

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Related Devices (Code: KCT)

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.

K253187SteriBest® Sterilization Tray SystemMastel SurgicalK260726Straumann® ProClean™ Cassette (041.800 ; 041.801)Institut Straumann AGK252854SteriTite Container System with MediTray ProductsCase Medical, Inc.K253791PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula System LidDePuy Mitek, Inc.K251614Stainless Steel Surgical KitsDentsply Sirona, Inc.K251756Sterilization TraysParagon Implant Mfg., LLC

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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