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FDA 510(k) clearance · back to tracker

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

Medtronic Sofamor Danek USA, Inc. cleared K253656 on 2026-06-05, decision: substantially equivalent

K-number

K253656

Sponsor

Medtronic Sofamor Danek USA, Inc.

Device

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

Class

Class II

Decision

Substantially Equivalent

Decision date

2026-06-05

Product code

GEI

Advisory committee

General, Plastic Surgery

Medical specialty

General, Plastic Surgery

Regulation number

878.4400

Official FDA record

Open K253656on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

openFDA JSON

Raw record →

Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.

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Drop K253656 into Compass and start a substantial-equivalence draft.

Compass pulls the predicate's intended use, technological characteristics, and performance data, maps them against your device, and produces a draft SE table aligned to FDA's 510(k) program guidance.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.