Catalog Number

-

Brand Name

L-Shaped Fracture Plate 4 holes, left 2.5/2.8mm Sterile

Version/Model Number

20717

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

K162674

Product Code

HRS

Product Code Name

Plate, Fixation, Bone

Public Device Record Key

16dfc255-9018-46fc-8094-20cf58b624b7

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 13, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-