FDA 510(k)

Système de fusion cervicale PEEK™ anatomique avec nanotechnologie

Numéro K : K230936 · 2023-06-02

Date de décision2023-06-02

Code produitODP

Comité consultatifOR

DécisionSubstantially Equivalent

Résumé du dispositif

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.

Questions fréquentes

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.

Essais cliniques associés

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Dispositifs connexes (Code : ODP)

K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.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 Spine K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC K260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.

Source officielle

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