Catalog Number

-

Brand Name

Axi+Line Bunion Correction System

Version/Model Number

SCR-3522NL

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

K152548

Product Code

HWC

Product Code Name

Screw, Fixation, Bone

Public Device Record Key

b329f860-6bca-4903-918c-3c7b6b188d20

Public Version Date

September 23, 2022

Public Version Number

4

DI Record Publish Date

March 31, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-