Guided DAS Surgical Kit— 510(k) K243425

Substantially Equivalent

Talladium España, SL

FDA 510(k) clearance K243425 for Guided DAS Surgical Kit, Substantially Equivalent on 2025-07-22. Applicant: Talladium España, SL. Device class: 2.

Clearance details

Applicant: Talladium España, SL
Product code: Code KCT
Device class: Class 2
Regulation: 21 CFR 880.6850
Advisory panel: General Hospital
Date received: 2024-11-04
Decision date: 2025-07-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lleida, ES

Download summary PDF View on FDA.gov ↗

Recent devices under product code KCT

K253988 — LiteSet Trays2026-09-08
K261935 — Surgical and Prosthetic Trays2026-09-04
K253187 — SteriBest® Sterilization Tray System2026-06-18
K252854 — SteriTite Container System with MediTray Products2026-06-03
K260726 — Straumann® ProClean Cassette (041.800; 041.801)2026-06-03

More clearances from Talladium España, SL

K243732 — Multi-Unit DAS System2026-01-29
K243530 — Dynamic TiBase2025-05-30
K241170 — Dynamic TiBase; TRI Screws2024-10-21
K231559 — Multi-Unit DAS System2023-11-17
K232151 — Dynamic TiBase2023-10-17

Data sourced from openFDA. This site is unofficial and independent of the FDA.