FDA 510(k)

Integral Titanium Cervical Interbody

K-Nummer: K222015 · 2023-07-05

AntragstellerNvision Biomedical Technologies, Inc.

Entscheidungsdatum2023-07-05

ProduktcodeODP

BeratungsausschussOR

EntscheidungSubstantially Equivalent

Produktübersicht

Integral Titanium Cervical Interbody is the device name listed in this FDA 510(k) record. The listed applicant is Nvision Biomedical Technologies, Inc.. It received FDA 510(k) clearance on 2023-07-05 under 510(k) number K222015. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the Integral Titanium Cervical Interbody?

Integral Titanium Cervical Interbody is a medical device that received FDA 510(k) clearance on 2023-07-05. The listed applicant is Nvision Biomedical Technologies, Inc.. The 510(k) number is K222015.

When did Integral Titanium Cervical Interbody receive FDA 510(k) clearance?

Integral Titanium Cervical Interbody received FDA 510(k) clearance on 2023-07-05, under 510(k) number K222015.

Who is the listed applicant for Integral Titanium Cervical Interbody?

The FDA 510(k) record lists Nvision Biomedical Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Integral Titanium Cervical Interbody?

The FDA product code for Integral Titanium Cervical Interbody is ODP.

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Verwandte Geräte (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.

Offizielle Quelle

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