Catalog Number

1450-8110

Brand Name

Aries-L Lateral Lumbar Interbody System

Version/Model Number

1450-8110

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

HWM

Product Code Name

Osteotome

Public Device Record Key

570f6483-28ea-4ad0-9469-a1f7e2791278

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

May 12, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-