Catalog Number

-

Brand Name

Leforte Neuro System Bone Plate

Version/Model Number

N12-ME-002-05

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

K091679,K141452,K112812,K103778

Product Code

GWO

Product Code Name

Plate, Cranioplasty, Preformed, Alterable

Public Device Record Key

ac084922-c1c3-47c3-92bd-0d57e89a4989

Public Version Date

February 05, 2021

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

-