FDA 510(k) clearance · back to tracker

OsteoCool RF Ablation System

Medtronic Sofamor Danek USA, Inc. cleared K182497 on 2019-01-15, decision: substantially equivalent

K-number

K182497

Sponsor

Medtronic Sofamor Danek USA, Inc.

Device

OsteoCool RF Ablation System

Class

Class II

Decision

Substantially Equivalent

Decision date

2019-01-15

Product code

GEI

Advisory committee

General, Plastic Surgery

Medical specialty

General, Plastic Surgery

Regulation number

878.4400

Official FDA record

Open K182497on accessdata.fda.gov →

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

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Source

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