Catalog Number

-

Brand Name

Additive Orthopaedic Bone Wedge System

Version/Model Number

AOEW-22-12

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

K153207

Product Code

HRS

Product Code Name

Plate, Fixation, Bone

Public Device Record Key

886230ea-0b8c-47c2-87ca-d512e4c783d0

Public Version Date

June 08, 2021

Public Version Number

2

DI Record Publish Date

March 05, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-