Duns Number:435428396
Device Description: Mendec Spine is an acrylic resin for the treatment of pathological fractures of the verteb Mendec Spine is an acrylic resin for the treatment of pathological fractures of the vertebral body using a vertebroplasty or kyphoplasty procedure.Mendec Spine is a medium-high viscosity acrylic resin (PMMA-based), highly radiopaque for syringe application.The device is sold disposable and sterile
Catalog Number
-
Brand Name
Mendec Spine
Version/Model Number
1230
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
-
Product Code
NDN
Product Code Name
Cement, Bone, Vertebroplasty
Public Device Record Key
1c2e0d87-cfc4-49ef-b410-6e12cc944fa7
Public Version Date
June 19, 2020
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 |