Duns Number:830350380
Device Description: BONE CEMENT CX01B KYPHON XPEDE W MXR US
Catalog Number
-
Brand Name
KYPHON® Xpede™ Bone Cement and KYPHON® Mixer Pack
Version/Model Number
CX01B
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
K102397
Product Code
NDN
Product Code Name
CEMENT, BONE, VERTEBROPLASTY
Public Device Record Key
979c6462-097d-4e33-82b9-25f585249f58
Public Version Date
June 19, 2020
Public Version Number
4
DI Record Publish Date
September 02, 2015
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 |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 13352 |
2 | A medical device with a moderate to high risk that requires special controls. | 26085 |
3 | A medical device with high risk that requires premarket approval | 190 |
U | Unclassified | 75 |