FDA 510(k)

CONFIDENCE High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw Systems

K-Number: K160879 · 2016-12-20

Decision Date2016-12-20

Product CodePML

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

CONFIDENCE High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw Systems is a medical device manufactured by Medos International Sàrl. It received FDA 510(k) clearance on 2016-12-20 under approval number K160879. The device is classified under product code PML. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CONFIDENCE High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw Systems?

CONFIDENCE High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw Systems is a medical device that received FDA 510(k) clearance on 2016-12-20. It is manufactured by Medos International Sàrl. The 510(k) number is K160879.

When was CONFIDENCE High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw Systems approved by the FDA?

CONFIDENCE High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw Systems received FDA 510(k) clearance on 2016-12-20, under approval number K160879.

What company makes CONFIDENCE High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw Systems?

CONFIDENCE High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw Systems is manufactured by Medos International Sàrl.

What is the FDA product code for CONFIDENCE High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw Systems?

The FDA product code for CONFIDENCE High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw Systems is PML.

Related Clinical Trials

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Related PubMed Literature

PMID: 40345136 A deployment safety case for AI-assisted prostate cancer diagnosis. Computers in biology and medicine (2025)

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Related Devices (Code: PML)

K152604KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw SetMedtronic Sofamor Danek USA, Incorporated K171938KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw SetMedtronic K180498NuVasive Reline Fenestrated Screws, High V+ Bone CementNu Vasive, Incorporated K172269FORTRESS Radiopaque Bone Cement (FORTRESS and FORTRESS-Plus), CREO® Fenestrated Screw System, REVLOK® Fenestrated Screw SystemGlobus Medical, Inc. K190526High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics , Ltd. K191148Medtronic HV-R Bone Cement, Kyphon Xpede Bone Cement, CD Horizon Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.