Catalog Number

69-AV-0011-2C

Brand Name

Dakota ALIF Plate System

Version/Model Number

69-AV-0011-2C

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 14, 2022

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

K212937

Product Code

KWQ

Product Code Name

Appliance, Fixation, Spinal Intervertebral Body

Public Device Record Key

f66e07a6-4808-421e-92b9-8d0cebcb3575

Public Version Date

July 19, 2022

Public Version Number

2

DI Record Publish Date

January 24, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-