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FDA 510(k)

Preference Elite Pedicle Screw System

K-Number: K162160 · 2016-11-18

ApplicantAmedica Corporation
Decision Date2016-11-18
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Preference Elite Pedicle Screw System is a medical device manufactured by Amedica Corporation. It received FDA 510(k) clearance on 2016-11-18 under approval number K162160. 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 Preference Elite Pedicle Screw System?

Preference Elite Pedicle Screw System is a medical device that received FDA 510(k) clearance on 2016-11-18. It is manufactured by Amedica Corporation. The 510(k) number is K162160.

When was Preference Elite Pedicle Screw System approved by the FDA?

Preference Elite Pedicle Screw System received FDA 510(k) clearance on 2016-11-18, under approval number K162160.

What company makes Preference Elite Pedicle Screw System?

Preference Elite Pedicle Screw System is manufactured by Amedica Corporation.

What is the FDA product code for Preference Elite Pedicle Screw System?

The FDA product code for Preference Elite 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

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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