FDA 510(k)

NIDO Pedicle Screw System

K-Number: K230974 · 2023-09-15

Decision Date2023-09-15

Product CodeNKB

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

NIDO Pedicle Screw System is a medical device manufactured by Kalitec Medical. It received FDA 510(k) clearance on 2023-09-15 under approval number K230974. 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 NIDO Pedicle Screw System?

NIDO Pedicle Screw System is a medical device that received FDA 510(k) clearance on 2023-09-15. It is manufactured by Kalitec Medical. The 510(k) number is K230974.

When was NIDO Pedicle Screw System approved by the FDA?

NIDO Pedicle Screw System received FDA 510(k) clearance on 2023-09-15, under approval number K230974.

What company makes NIDO Pedicle Screw System?

NIDO Pedicle Screw System is manufactured by Kalitec Medical.

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

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

Related Clinical Trials

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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)

Related Devices (Code: NKB)

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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.