Catalog Number

08.844.104S

Brand Name

Foot Osteotomy Wedge System

Version/Model Number

08.844.104S

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

K150394

Product Code

HRS

Product Code Name

Plate, fixation, bone

Public Device Record Key

54a6ff85-be19-48e5-860d-b59cc90d2cec

Public Version Date

June 08, 2021

Public Version Number

2

DI Record Publish Date

March 20, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-