Catalog Number

-

Brand Name

Leforte System Bone Screw / GBR System Bone Screw

Version/Model Number

16-AT-005

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

K023365,K033767,K091686,K143730

Product Code

DZE

Product Code Name

Implant, Endosseous, Root-Form

Public Device Record Key

7b191f2e-7321-4892-9bc4-b019dbb1c53f

Public Version Date

December 14, 2018

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

-