Catalog Number

-

Brand Name

Aileron TRX

Version/Model Number

132-2314-2

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K100407

Product Code

PEK

Product Code Name

Spinous Process Plate

Public Device Record Key

03c6f738-207b-4727-9ef7-32b4a7ecc41b

Public Version Date

February 01, 2022

Public Version Number

1

DI Record Publish Date

January 24, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-