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FDA 510(k)

Multi-Drive Interference Screw System

K-Number: K200428 · 2020-11-10

ApplicantNvision Biomedical Technologies, Inc.
Decision Date2020-11-10
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Multi-Drive Interference Screw System is a medical device manufactured by Nvision Biomedical Technologies, Inc.. It received FDA 510(k) clearance on 2020-11-10 under approval number K200428. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Multi-Drive Interference Screw System?

Multi-Drive Interference Screw System is a medical device that received FDA 510(k) clearance on 2020-11-10. It is manufactured by Nvision Biomedical Technologies, Inc.. The 510(k) number is K200428.

When was Multi-Drive Interference Screw System approved by the FDA?

Multi-Drive Interference Screw System received FDA 510(k) clearance on 2020-11-10, under approval number K200428.

What company makes Multi-Drive Interference Screw System?

Multi-Drive Interference Screw System is manufactured by Nvision Biomedical Technologies, Inc..

What is the FDA product code for Multi-Drive Interference Screw System?

The FDA product code for Multi-Drive Interference Screw System is MBI.

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Related PubMed Literature

PMID: 42168293 Comparative in vitro and in vivo assessment of three experimental extracellular matrix meshes for soft tissue remodeling. Scientific reports (2026) PMID: 40794850 Regulatory Approved Point-of-Care Diagnostics (FDA & Health Canada): A Comprehensive Framework for Analytical Validity, Clinical Validity, and Clinical Utility in Medical Devices. The journal of applied laboratory medicine (2025)

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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.

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