Catalog Number

-

Brand Name

AOS CAPTURED CORTICAL SCREW 4.2mm x 27.5mm

Version/Model Number

S8002-027

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 31, 2017

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

K132005

Product Code

HSB

Product Code Name

Rod, Fixation, Intramedullary And Accessories

Public Device Record Key

f4e88362-96b1-4d25-abc5-7ef84f1fea91

Public Version Date

June 24, 2020

Public Version Number

4

DI Record Publish Date

December 30, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-