Catalog Number

03-10-0460

Brand Name

Tether™

Version/Model Number

03-10-0460

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 02, 2016

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

K010466

Product Code

KWQ

Product Code Name

APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Public Device Record Key

0d4f6535-7dee-4549-9b7c-b20b72391d02

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 24, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-