Catalog Number

550316

Brand Name

JAZZ System

Version/Model Number

Tensioner Gen. II - Universal 90° Stem

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

K151740,K160226,K170730,K171881,K182771,K191217

Product Code

OWI

Product Code Name

Bone Fixation Cerclage, Sublaminar

Public Device Record Key

e430331c-f3f3-4d26-a2ed-c5e727361af5

Public Version Date

September 27, 2019

Public Version Number

5

DI Record Publish Date

September 24, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-