Catalog Number

-

Brand Name

OIC Variable Angle Small Fragment Locking Plate System

Version/Model Number

ST-3534

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K140357

Product Code

HWC

Product Code Name

Screw, Fixation, Bone

Public Device Record Key

c31865d0-0364-4276-9d69-df2710a483c3

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

February 01, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-