Catalog Number

SR-0314

Brand Name

Specials

Version/Model Number

SR-0314

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 19, 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

-

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

K160902

Product Code

KWQ

Product Code Name

Appliance, fixation, spinal intervertebral body

Public Device Record Key

3a69ea54-2e15-46e5-86d5-6582a5bb68fc

Public Version Date

April 19, 2022

Public Version Number

3

DI Record Publish Date

September 24, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-