Catalog Number

PK-SFP2708T

Brand Name

Procedure Kit Straight Fibula Plate 8 hole 2.7mm Cortical Screws Ti

Version/Model Number

PK-SFP2708T

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"

Yes

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

K180736

Product Code

HRS

Product Code Name

Plate, Fixation, Bone

Public Device Record Key

171a8d9e-e1f8-41c7-9ba7-656c737c527d

Public Version Date

January 14, 2022

Public Version Number

3

DI Record Publish Date

September 06, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-