ACIF - Anterior Cervical Interbody Fusion System - 14X16 6mm 6 Degree - NVISION BIOMEDICAL TECHNOLOGIES, INC.

Duns Number:047486041

Device Description: 14X16 6mm 6 Degree

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More Product Details

Catalog Number

-

Brand Name

ACIF - Anterior Cervical Interbody Fusion System

Version/Model Number

AC-606-L

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K142328

Product Code Details

Product Code

ODP

Product Code Name

Intervertebral Fusion Device With Bone Graft, Cervical

Device Record Status

Public Device Record Key

33f376d3-a126-4ad2-8be5-cd2380ced739

Public Version Date

February 24, 2020

Public Version Number

7

DI Record Publish Date

October 19, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NVISION BIOMEDICAL TECHNOLOGIES, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 461
2 A medical device with a moderate to high risk that requires special controls. 1046