Catalog Number

3711-G13610

Brand Name

NILE™ Spinal System

Version/Model Number

3711-G13610

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K103797

Product Code

JDQ

Product Code Name

CERCLAGE, FIXATION

Public Device Record Key

4743da3e-5f41-4994-880e-48c5e0fdc5f6

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 30, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-