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FDA 510(k)

Anatomic PEEK™ Cervical Fusion System with Nanotechnology

K-Number: K230936 · 2023-06-02

ApplicantNanovis, LLC
Decision Date2023-06-02
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Anatomic PEEK™ Cervical Fusion System with Nanotechnology is the device name listed in this FDA 510(k) record. The listed applicant is Nanovis, LLC. It received FDA 510(k) clearance on 2023-06-02 under 510(k) 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. The listed applicant is Nanovis, LLC. The 510(k) number is K230936.

When did Anatomic PEEK™ Cervical Fusion System with Nanotechnology receive FDA 510(k) clearance?

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

Who is the listed applicant for Anatomic PEEK™ Cervical Fusion System with Nanotechnology?

The FDA 510(k) record lists Nanovis, LLC as the applicant. This does not by itself establish the device manufacturer.

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 records listing Nanovis, LLC as applicant

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K241605Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System with NanotechnologyK203452Nano FortiFix® SystemK191822Nano FortiCore, FortiCoreK171312FortiCore®K161485Nanovis Intervertebral Body Fusion System and Forticore(R)K160874Nanovis Intervertebral Body Fusion System and FortiCore®

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Related Devices (Code: ODP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K2530413d Cage CervicalFims Co., Ltd.K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior Lumbar Cage; Aero® -C Cervical Cage System; AVS® Anchor-C Cervical Cage System; AVS® TL PEEK Spacer; AVS® PL PEEK Spacers; AVS® Navigator PEEK Spacer; AVS® AS PEEK Spacer; Monterey™ AL Interbody System; Aleutian IBF System; Cascadia Interbody System; Chesapeake Stabilization System; Sahara Stabilization System; SANTORINI™ Corpectomy Cage System; MOJAVE Interbody System; VLIFT VERTEBRAL BODY REPLACEMStryker SpineK254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLCK260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.K260850OSTEOMNI SPINAL CAGES SYSTEMOsteomni, Inc.K260549ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemZsfab, Inc.

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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