Catalog Number

-

Brand Name

CORTICAL BONE SCREW 3.5mm x 26mm

Version/Model Number

8110-026

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

K103513

Product Code

HWC

Product Code Name

Screw, Fixation, Bone

Public Device Record Key

b13b01e2-91e2-4138-b7f7-69aa235b48da

Public Version Date

June 24, 2020

Public Version Number

3

DI Record Publish Date

May 01, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-