Catalog Number

SP-2

Brand Name

Foot Plates

Version/Model Number

SP-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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K192696

Product Code

HRS

Product Code Name

Plate, fixation, bone

Public Device Record Key

e4ed0c94-9a58-4985-8050-b758f76729c1

Public Version Date

January 28, 2020

Public Version Number

1

DI Record Publish Date

January 20, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-