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FDA 510(k)

NANOVIS INTERVERTEBRAL BODY FUSION SYSTEM

K-Number: K110442 · 2011-11-09

ApplicantNanovis, LLC
Decision Date2011-11-09
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

NANOVIS INTERVERTEBRAL BODY FUSION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Nanovis, LLC. It received FDA 510(k) clearance on 2011-11-09 under 510(k) number K110442. 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 NANOVIS INTERVERTEBRAL BODY FUSION SYSTEM?

NANOVIS INTERVERTEBRAL BODY FUSION SYSTEM is a medical device that received FDA 510(k) clearance on 2011-11-09. The listed applicant is Nanovis, LLC. The 510(k) number is K110442.

When did NANOVIS INTERVERTEBRAL BODY FUSION SYSTEM receive FDA 510(k) clearance?

NANOVIS INTERVERTEBRAL BODY FUSION SYSTEM received FDA 510(k) clearance on 2011-11-09, under 510(k) number K110442.

Who is the listed applicant for NANOVIS INTERVERTEBRAL BODY FUSION SYSTEM?

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 NANOVIS INTERVERTEBRAL BODY FUSION SYSTEM?

The FDA product code for NANOVIS INTERVERTEBRAL BODY FUSION SYSTEM is ODP.

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Other records listing Nanovis, LLC as applicant

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.

K241605Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System with NanotechnologyK230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyK203452Nano FortiFix® SystemK191822Nano FortiCore, FortiCoreK171312FortiCore®K161485Nanovis Intervertebral Body Fusion System and Forticore(R)

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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.

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 SpineK254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLCK260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.

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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