510(k) Report

Devices descending from K161949

7 later devices reach OsteoCool V-3 RF Ablation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192406AveCure BT Microwave Ablation SystemMedwaves, Inc.20200—
+1K182497OsteoCool RF Ablation SystemMedtronic Sofamor Danek USA, Inc.20195—
+2K233830OsteoCool™ 2.0 RF Ablation SystemMedtronic Sofamor Danek USA, Inc.20241—
+2K223303Spinery™ RF Ablation SystemAxon Spine Medical System20230—
+2K221074OptaBlate RF Generator, OptaBlate Probes, OptaBlate Microinfuser Infusion DeviceStryker Corporation20222—
+3K253656OsteoCool™ RF Ablation System; OsteoCool™ 2.0 RF Ablation SystemMedtronic Sofamor Danek USA, Inc.20260—
+3K250327OptaBlate Radiofrequency (RF) Generator SystemStryker Instruments20250—