Catalog Number

00-1506-3116

Brand Name

Pediatric Nailing Platform Femur

Version/Model Number

00-1506-3116

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

K220679

Product Code

HSB

Product Code Name

ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Public Device Record Key

8592d1ed-3a78-4202-9869-78ccc6237883

Public Version Date

September 26, 2022

Public Version Number

1

DI Record Publish Date

September 16, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-