FDA 510(k)

Anatomic PEEK Cervical Fusion System with Nanotechnology

K-Number: K230936 · 2023-06-02

Decision Date2023-06-02

Product CodeODP

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Anatomic PEEK Cervical Fusion System with Nanotechnology is a medical device manufactured by Nanovis, LLC. It received FDA 510(k) clearance on 2023-06-02 under approval number K230936. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Anatomic PEEK Cervical Fusion System with Nanotechnology?

Anatomic PEEK Cervical Fusion System with Nanotechnology is a medical device that received FDA 510(k) clearance on 2023-06-02. It is manufactured by Nanovis, LLC. The 510(k) number is K230936.

When was Anatomic PEEK Cervical Fusion System with Nanotechnology approved by the FDA?

Anatomic PEEK Cervical Fusion System with Nanotechnology received FDA 510(k) clearance on 2023-06-02, under approval number K230936.

What company makes Anatomic PEEK Cervical Fusion System with Nanotechnology?

Anatomic PEEK Cervical Fusion System with Nanotechnology is manufactured by Nanovis, LLC.

What is the FDA product code for Anatomic PEEK Cervical Fusion System with Nanotechnology?

The FDA product code for Anatomic PEEK Cervical Fusion System with Nanotechnology is ODP.

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Other Devices by Nanovis, LLC

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Related Devices (Code: ODP)

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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.