FDA 510(k)

Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw System

K-Number: K241034 · 2024-06-12

Decision Date2024-06-12

Product CodePML

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw System is a medical device manufactured by Medacta International S.A.. It received FDA 510(k) clearance on 2024-06-12 under approval number K241034. 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 Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw System?

Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw System is a medical device that received FDA 510(k) clearance on 2024-06-12. It is manufactured by Medacta International S.A.. The 510(k) number is K241034.

When was Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw System approved by the FDA?

Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw System received FDA 510(k) clearance on 2024-06-12, under approval number K241034.

What company makes Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw System?

Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw System is manufactured by Medacta International S.A..

What is the FDA product code for Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw System?

The FDA product code for Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw System is PML.

Related Clinical Trials

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Related PubMed Literature

PMID: 38493931 Establishing finite element model credibility of a pedicle screw system under compression-bending: An end-to-end example of the ASME V&V 40 standard. Methods (San Diego, Calif.) (2024) PMID: 37209414 Adverse events associated with Aveir Journal of cardiovascular electrophysiology (2023) PMID: 30035086 Translational research of one dynamic hip screw system-from the SCI to the FDA. Journal of orthopaedic translation (2016)

Other Devices by Medacta International S.A.

K163311GMK Revision Femoral Distal Augmentation K162061M.U.S.T. Pedicle Screw System K153273MySpine Pedicle Screw Placement Guides - LP K171058Medacta Shoulder System: Threaded Glenoid Baseplate K173267MasterLoc Stem: Lateralized Plus K170690M-Vizion Femoral Revision System

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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. K190526High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics , Ltd.

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.