Duns Number:557799209
Device Description: The GUARDIAN Inflatable Bone Expander System is designed to reduce spinal compression frac The GUARDIAN Inflatable Bone Expander System is designed to reduce spinal compression fracture and restore sagittal alignment. By creating a space in the vertebral body to facilitate the insertion of bone cement and using cement dispensing plunger, the major benefits of GUARDIAN Inflatable Bone Expander System are the significant reduction in back pain and increase patient’s functional abilities, allow a return it the previous level of activity.
Catalog Number
-
Brand Name
GUARDIAN Inflatable Bone Expander System
Version/Model Number
BMK-OP
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K111593,K111593
Product Code
HRX
Product Code Name
Arthroscope
Public Device Record Key
e648d8bc-402d-4c36-b002-b8e6ff6368af
Public Version Date
May 06, 2020
Public Version Number
5
DI Record Publish Date
February 14, 2018
Package DI Number
08809255544817
Quantity per Package
10
Contains DI Package
08809255542813
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 149 |