Catalog Number

LP01-0202

Brand Name

Elatus Lumbar Plate System

Version/Model Number

LP01-0202

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)

Yes

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

-

Product Code

FZX

Product Code Name

Guide, Surgical, Instrument

Public Device Record Key

536bd690-c660-412f-8788-deb1c6611621

Public Version Date

October 26, 2021

Public Version Number

2

DI Record Publish Date

September 13, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-