Catalog Number

01-9080-18U

Brand Name

Lumbar Interbody Fusion System (OLLIF)

Version/Model Number

01-9080-18U

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

K173947,K173947,K173947,K173947

Product Code

MAX

Product Code Name

Intervertebral Fusion Device With Bone Graft, Lumbar

Public Device Record Key

e345c9d8-b551-44c5-b648-89b7569f5961

Public Version Date

August 22, 2022

Public Version Number

1

DI Record Publish Date

August 12, 2022

Package DI Number

10850014575776

Quantity per Package

10

Contains DI Package

00850014575779

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-