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FDA 510(k)

FOCUS Pedicle Screw System

K-Number: K180458 · 2018-04-17

ApplicantNvision Biomedical Technologies, LLC
Decision Date2018-04-17
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

FOCUS Pedicle Screw System is a medical device manufactured by Nvision Biomedical Technologies, LLC. It received FDA 510(k) clearance on 2018-04-17 under approval number K180458. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FOCUS Pedicle Screw System?

FOCUS Pedicle Screw System is a medical device that received FDA 510(k) clearance on 2018-04-17. It is manufactured by Nvision Biomedical Technologies, LLC. The 510(k) number is K180458.

When was FOCUS Pedicle Screw System approved by the FDA?

FOCUS Pedicle Screw System received FDA 510(k) clearance on 2018-04-17, under approval number K180458.

What company makes FOCUS Pedicle Screw System?

FOCUS Pedicle Screw System is manufactured by Nvision Biomedical Technologies, LLC.

What is the FDA product code for FOCUS Pedicle Screw System?

The FDA product code for FOCUS Pedicle Screw System is NKB.

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Related PubMed Literature

PMID: 41487949 Verification, validation, and uncertainty quantification of finite element analysis results for pedicle screw assemblies under ASTM F1717 flexion and extension testing. Frontiers in bioengineering and biotechnology (2025)

Other Devices by Nvision Biomedical Technologies, LLC

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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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