Medtronic Sofamor Danek USA, Inc.
OsteoCool RF Ablation System; OsteoCool 2.0 RF Ablation System
SKU K253656UPC GEI
In Stock
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IIFDA 510(k) Cleared (K253656)
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Free shipping on orders over $99 · 30-day returns
Medtronic Sofamor Danek USA, Inc.
Free shipping on orders over $99 · 30-day returns
OsteoCool RF Ablation System; OsteoCool 2.0 RF Ablation System is an FDA 510(k)-cleared medical device (K253656) manufactured by Medtronic Sofamor Danek USA, Inc.. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 4, 2026. Regulation: 8.
