Catalog Number

1450-7000

Brand Name

Aries-L Lateral Lumbar Interbody System

Version/Model Number

1450-7000

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

-

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

K181347

Product Code

GAC

Product Code Name

Rasp, Surgical, General & Plastic Surgery

Public Device Record Key

5f9f86c7-1a6f-4cf4-a6ea-c5ce041a33cb

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

May 11, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-