Catalog Number

FHPA-S3-00-23-B

Brand Name

FlareHawk

Version/Model Number

II-1-0176

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 07, 2020

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

K160076

Product Code

MAX

Product Code Name

Intervertebral Fusion Device With Bone Graft, Lumbar

Public Device Record Key

ee697033-ff37-4421-90ca-cca2b751458f

Public Version Date

May 13, 2022

Public Version Number

6

DI Record Publish Date

January 30, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-