Duns Number:435428396
Device Description: Mendec Spine Kit is a device for the treatment of pathological fractures of the vertebral Mendec Spine Kit is a device for the treatment of pathological fractures of the vertebral body using a vertebroplasty procedure.The device is composed by an acrylic resin and a delivery system.
Catalog Number
-
Brand Name
Mendec Spine Kit
Version/Model Number
13C2000
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
K062452
Product Code
NDN
Product Code Name
Cement, Bone, Vertebroplasty
Public Device Record Key
3997551d-9723-41eb-84d9-56cc8b5628b0
Public Version Date
October 08, 2018
Public Version Number
3
DI Record Publish Date
October 06, 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 | 37 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 52 |