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Recognized a 510(k)/PMA number — showing its clearance record and devices.

Clearance record K243265

Ion 3D · SurGenTec, LLC · decided 2024-12-04 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
ION Facet Screw SystemTI-AE-55Surgentec, LLCMRW00858406007952
ION Facet Screw SystemTI-AE-60-35Surgentec, LLCMRW00850040139037
ION Facet Screw SystemTI-AE-65-45Surgentec, LLCMRW00850040139099
ION Large Tray SR12-7013Surgentec, LLCMRW00810131882174
ION Facet Screw SystemTI-AE-70Surgentec, LLCMRW00810131881726
Impactor Large SR12-6401Surgentec, LLCMRW00810131882068
ION Cervical Tray SR12-7011Surgentec, LLCMRW00810131882723
ION Facet Screw SystemTI-AE-65-25Surgentec, LLCMRW00850040139075
ION Cervical Disposable Instrument KitTI-C-1000Surgentec, LLCMRW00810131881788
6.5/7.0 Drill Bit SR12-6442Surgentec, LLCMRW00810131881252
ION Facet Screw SystemTI-AE-55-35Surgentec, LLCMRW00858406007983
ION Caddy with Metal Plate SR12-7024Surgentec, LLCMRW00810131881986
Serrated Rasp - Large SR12-6406Surgentec, LLCMRW00810131882075
ION Facet Screw SystemTI-AE-55-25Surgentec, LLCMRW00858406007976
ION Facet Screw SystemTI-AE-65Surgentec, LLCMRW00850040139051
ION Facet Screw SystemTI-AE-55-45Surgentec, LLCMRW00858406007990
ION Disposable Instrument KitTI-K-1000Surgentec, LLCMRW00810131881795
ION 60 Facet Implant - SterileTI-K-60Surgentec, LLCMRW00810131881818
ION Facet Screw SystemTI-AE-65-35Surgentec, LLCMRW00850040139082
ION Facet Screw SystemTI-AE-75Surgentec, LLCMRW00810131882754
Plastic Removal Sleeve - Standard - 7.0-7.5 SR12-6450Surgentec, LLCMRW00810131882419
Facet Locator - Large SR12-6407Surgentec, LLCMRW00810131882051
ION 65 Facet Implant - SterileTI-K-65Surgentec, LLCMRW00810131881825
ION Facet Screw SystemTI-AE-60-45Surgentec, LLCMRW00850040139044
Plastic Removal Sleeve - Standard - 5.5-6.5 SR12-6449Surgentec, LLCMRW00810131882426