Catalog Number

550335

Brand Name

JAZZ System

Version/Model Number

JAZZ CLAW - Implant Holder Hook / Blocker

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

K160226,K170730,K171881,K182771,K191217

Product Code

OWI

Product Code Name

Bone Fixation Cerclage, Sublaminar

Public Device Record Key

70ec18f7-ec29-4728-b3c8-3a51c6cc58a8

Public Version Date

April 21, 2021

Public Version Number

8

DI Record Publish Date

May 25, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-