Catalog Number

-

Brand Name

Pagoda

Version/Model Number

158-3405B

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 17, 2016

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

K131785

Product Code

MNH

Product Code Name

Orthosis, spondylolisthesis spinal fixation

Public Device Record Key

3608518d-fa24-4c7c-99e6-0aaa55e69c0b

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

July 15, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-