Catalog Number

60001645-00-0

Brand Name

FITBONE®

Version/Model Number

CEl 120V

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

K203399

Product Code

HSB

Product Code Name

Rod, Fixation, Intramedullary And Accessories

Public Device Record Key

cf999814-3d3d-4c72-9339-5faff4c8d328

Public Version Date

April 26, 2021

Public Version Number

1

DI Record Publish Date

April 17, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-