Duns Number:058864308
Device Description: The HiMAX Plus Implant System is a Nitinol Superelastic bone staple for use in surgery of The HiMAX Plus Implant System is a Nitinol Superelastic bone staple for use in surgery of the hand and foot for bone fragment osteotomy fixation and joint arthrodesis.
Catalog Number
7420-2020
Brand Name
HiMAX Plus Implant System
Version/Model Number
HiMAX Plus Single Packaged Implant, 20mm x 20mm x 20mm
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
JDR
Product Code Name
Staple, Fixation, Bone
Public Device Record Key
956d1b5f-7f1c-462c-aec3-1dfb6bc83d64
Public Version Date
November 23, 2021
Public Version Number
2
DI Record Publish Date
December 11, 2019
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 |