Facet Fixx™ Facet Screw System - Facet Fixx, Screw, Full Thread, No Washer, Ø5.0 x - NEXXT SPINE, LLC

Duns Number:003489810

Device Description: Facet Fixx, Screw, Full Thread, No Washer, Ø5.0 x 45mm

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More Product Details

Catalog Number

-

Brand Name

Facet Fixx™ Facet Screw System

Version/Model Number

14-12-5045

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K131417

Product Code Details

Product Code

MRW

Product Code Name

System, Facet Screw Spinal Device

Device Record Status

Public Device Record Key

d7f7570c-2c66-4cf6-b291-8e756a18b580

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

July 23, 2015

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