Catalog Number

-

Brand Name

KYPHON Xpander II Inflatable Bone Tamp

Version/Model Number

KX203

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

K101864

Product Code

HXG

Product Code Name

TAMP

Public Device Record Key

93a3cf03-1a25-4947-9991-86c9bfe7a0de

Public Version Date

January 07, 2019

Public Version Number

1

DI Record Publish Date

December 06, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-