Catalog Number

00-1147-160-72

Brand Name

Zimmer® Cannulated Screw System

Version/Model Number

00-1147-160-72

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

Yes

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

K003496,K102903

Product Code

HWC

Product Code Name

Screw, fixation, bone

Public Device Record Key

54f56fc0-c17e-45a6-ae1a-f1a005a7a57d

Public Version Date

October 14, 2021

Public Version Number

2

DI Record Publish Date

September 11, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-