Duns Number:690024786
Device Description: The SpineKure Kyphoplasty System is designed to reduce spinal compression fracture and res
Catalog Number
-
Brand Name
SpineKure Kyphoplasty System
Version/Model Number
Balloon Inflator (SBI)
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
K172871
Product Code
HRX
Product Code Name
Arthroscope
Public Device Record Key
76ccc849-24fe-44a2-8232-15ed952ee9e0
Public Version Date
May 06, 2020
Public Version Number
2
DI Record Publish Date
April 17, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 6 |