Catalog Number

SMBU5243

Brand Name

Symbionic Leg

Version/Model Number

SMBU5243

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 31, 2018

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

-

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

-

Product Code

ISW

Product Code Name

ASSEMBLY, KNEE/SHANK/ANKLE/FOOT, EXTERNAL

Public Device Record Key

3124cbe2-8e89-40a8-bb6a-1c5d8483c9eb

Public Version Date

March 09, 2021

Public Version Number

2

DI Record Publish Date

May 16, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-