Catalog Number

-

Brand Name

Amendia

Version/Model Number

10-03-6550-2

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

-

Product Code

MNH

Product Code Name

Orthosis, Spondylolisthesis Spinal Fixation

Public Device Record Key

2e041ca9-a0c5-46aa-96a6-362b8aede350

Public Version Date

December 03, 2018

Public Version Number

4

DI Record Publish Date

September 25, 2014

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-