FDA 510(k)

High V+ Bone Cement, CarboClear® Fenestrated Pedicle Screws

K-Number: K190526 · 2019-09-19

Decision Date2019-09-19

Product CodePML

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

High V+ Bone Cement, CarboClear® Fenestrated Pedicle Screws is a medical device manufactured by CarboFix Orthopedics , Ltd.. It received FDA 510(k) clearance on 2019-09-19 under approval number K190526. 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 High V+ Bone Cement, CarboClear® Fenestrated Pedicle Screws?

High V+ Bone Cement, CarboClear® Fenestrated Pedicle Screws is a medical device that received FDA 510(k) clearance on 2019-09-19. It is manufactured by CarboFix Orthopedics , Ltd.. The 510(k) number is K190526.

When was High V+ Bone Cement, CarboClear® Fenestrated Pedicle Screws approved by the FDA?

High V+ Bone Cement, CarboClear® Fenestrated Pedicle Screws received FDA 510(k) clearance on 2019-09-19, under approval number K190526.

What company makes High V+ Bone Cement, CarboClear® Fenestrated Pedicle Screws?

High V+ Bone Cement, CarboClear® Fenestrated Pedicle Screws is manufactured by CarboFix Orthopedics , Ltd..

What is the FDA product code for High V+ Bone Cement, CarboClear® Fenestrated Pedicle Screws?

The FDA product code for High V+ Bone Cement, CarboClear® Fenestrated Pedicle Screws is PML.

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Related Devices (Code: PML)

K160879CONFIDENCE High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw SystemsMedos International Sàrl 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. K191148Medtronic HV-R Bone Cement, Kyphon Xpede Bone Cement, CD Horizon Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc.

Official Source

View on FDA Database →

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