Duns Number:058864308
Device Description: The MotoBAND™ CP DynaForce® MPJ Implant System is a bone plating system indicated for stab The MotoBAND™ CP DynaForce® MPJ Implant System is a bone plating system indicated for stabilization and fixation of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes. It consist of plates and screws. Certain plates in the system are compatible with the MotoCLIP/DynaForce Superelastic Fixation System.
Catalog Number
750L-5025
Brand Name
MotoBAND™ CP DynaForce® MTP
Version/Model Number
DynaForce MTP Long Plate, 5deg valgus, 5deg dorsiflexion, 25mm Clip - Left
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
-
Product Code
HRS
Product Code Name
Plate, Fixation, Bone
Public Device Record Key
e3763585-4fd6-40a9-8245-001f724edb8e
Public Version Date
November 23, 2021
Public Version Number
2
DI Record Publish Date
March 19, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 59 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 713 |