Catalog Number

-

Brand Name

Neobiotech Implant System

Version/Model Number

CTS2007

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

K160991

Product Code

DZL

Product Code Name

Screw, Fixation, Intraosseous

Public Device Record Key

b76e5baa-5b2c-44f5-98b0-959a26acf277

Public Version Date

December 13, 2018

Public Version Number

1

DI Record Publish Date

November 12, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-