Catalog Number

311-0208

Brand Name

FX Solutions

Version/Model Number

PRCT2 SIZE 08 CEMENTLESS

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K130759

Product Code

HRS

Product Code Name

Plate, Fixation, Bone

Public Device Record Key

1fe8053a-9221-4cb3-8b64-374d6e3b163c

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

June 09, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-