S.I.N. Instruments Kits— 510(k) K262084

Name: FDA 510(k) clearance K262084
Creator: U.S. Food and Drug Administration
Published: 2026-10-22

Substantially Equivalent

S.I.N. Implant System Ltda

FDA 510(k) clearance K262084 for S.I.N. Instruments Kits, Substantially Equivalent on 2026-10-22. Applicant: S.I.N. Implant System Ltda. Device class: 2.

Clearance details

Applicant: S.I.N. Implant System Ltda
Product code: Product code KCT
Device class: Class 2
Regulation: 21 CFR 880.6850
Advisory panel: General Hospital
Date received: 2026-06-22
Decision date: 2026-10-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: São Paulo, BR

Download summary PDF View on FDA.gov ↗

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