Struxxure® Plate System - Lateral Plate Inserter - NEXXT SPINE, LLC

Duns Number:003489810

Device Description: Lateral Plate Inserter

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More Product Details

Catalog Number

-

Brand Name

Struxxure® Plate System

Version/Model Number

I63-02-04

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

-

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

K202192

Product Code Details

Product Code

KWQ

Product Code Name

Appliance, Fixation, Spinal Intervertebral Body

Device Record Status

Public Device Record Key

4b93824f-082c-4da1-ac52-1579dd600141

Public Version Date

January 08, 2021

Public Version Number

1

DI Record Publish Date

December 31, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NEXXT SPINE, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1102
2 A medical device with a moderate to high risk that requires special controls. 4259
U Unclassified 91