Catalog Number

07.00766.701

Brand Name

Dynesys

Version/Model Number

07.00766.701

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

NQP

Product Code Name

Posterior Metal/Polymer Spinal System, Fusion

Public Device Record Key

7ac1b77a-5ff9-4fb4-bdcb-33d3b826055b

Public Version Date

March 10, 2022

Public Version Number

3

DI Record Publish Date

May 30, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-