TIDAL Fusion Cage System— 510(k) K242356

Substantially Equivalent

Restor3D, Inc.

FDA 510(k) clearance K242356 for TIDAL Fusion Cage System, Substantially Equivalent on 2025-03-24. Applicant: Restor3D, Inc.. Device class: 2.

Clearance details

Applicant: Restor3D, Inc.
Product code: Code SAI
Device class: Class 2
Regulation: 21 CFR 888.3020
Advisory panel: Orthopedic
Date received: 2024-08-08
Decision date: 2025-03-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Durham, NC, US

Download summary PDF View on FDA.gov ↗

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