Catalog Number

003-BB0E

Brand Name

InFront

Version/Model Number

003-BB0E

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

June 24, 2026

Issuing Agency

In HIBCC

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

-

Product Code

MAX

Product Code Name

Intervertebral Fusion Device With Bone Graft, Lumbar

Public Device Record Key

e0cd2f0a-5f3d-4a0e-bccb-6f35fa36d8b3

Public Version Date

February 24, 2020

Public Version Number

3

DI Record Publish Date

June 24, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-