FDA 510(k)

SEURAT Universal Pedicle Screw System

K-Number: K173185 · 2018-02-14

Decision Date2018-02-14

Product CodeNKB

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

SEURAT Universal Pedicle Screw System is a medical device manufactured by Ctl Medical Corporation. It received FDA 510(k) clearance on 2018-02-14 under approval number K173185. 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 SEURAT Universal Pedicle Screw System?

SEURAT Universal Pedicle Screw System is a medical device that received FDA 510(k) clearance on 2018-02-14. It is manufactured by Ctl Medical Corporation. The 510(k) number is K173185.

When was SEURAT Universal Pedicle Screw System approved by the FDA?

SEURAT Universal Pedicle Screw System received FDA 510(k) clearance on 2018-02-14, under approval number K173185.

What company makes SEURAT Universal Pedicle Screw System?

SEURAT Universal Pedicle Screw System is manufactured by Ctl Medical Corporation.

What is the FDA product code for SEURAT Universal Pedicle Screw System?

The FDA product code for SEURAT Universal 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 Ctl Medical Corporation

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Related Devices (Code: NKB)

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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.