Catalog Number

60000412

Brand Name

FITBONE®

Version/Model Number

REAM D9.0 L100 L480 FC

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

-

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

K163368

Product Code

HSB

Product Code Name

Rod, Fixation, Intramedullary And Accessories

Public Device Record Key

ef6f1c08-af67-4487-8d50-90028ec896b7

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

December 12, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-