Duns Number:058864308
Device Description: MotoCLIP™ is a bone staple for use in surgery of the hand and foot bone fragment osteotomy MotoCLIP™ is a bone staple for use in surgery of the hand and foot bone fragment osteotomy fixation and joint arthrodesis
Catalog Number
2442-2522
Brand Name
MotoCLIP™
Version/Model Number
Single Pack Implant
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
K142727
Product Code
JDR
Product Code Name
Staple, Fixation, Bone
Public Device Record Key
3813e1fb-5fc8-48a4-85a5-9532f8a087e6
Public Version Date
November 23, 2021
Public Version Number
4
DI Record Publish Date
October 15, 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 | 59 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 713 |