OsteoCool™ RF Ablation System; OsteoCool™ 2.0 RF Ablation System

Country / Region:United States (US)Submission type:Traditional

Product code GEI· 21 CFR 878.4400

Company

United States (US)

Product code

GEI

21 CFR 878.4400

Predicate devices

Cited in this 510(k)

Cited as predicate

Device details

FDA 510(k) registration fields

K number: K253656
Device name: OsteoCool™ RF Ablation System; OsteoCool™ 2.0 RF Ablation System
Company: Medtronic Sofamor Danek USA, Inc.
Country / Region: United States(US)
Product code: GEI
Device class: Class 2
Regulation number: 21 CFR 878.4400
Date received: 2025-11-20
Decision date: 2026-06-05
Submission type: Traditional

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