Duns Number:942377524
Device Description: The Integra® MemoFix® staple is a one piece singleuse nickel titanium alloy bone fixation The Integra® MemoFix® staple is a one piece singleuse nickel titanium alloy bone fixation device intendedto be permanently implanted. The device is indicatedfor the fixation of osteotomies and joint arthrodesisof the hands and feet. The implant consists of twolegs connected by a bridge and is offered in multiplecombinations of bridge widths and leg lengths toaccommodate various anatomies.
Catalog Number
MS252222
Brand Name
Integra® MemoFix®
Version/Model Number
MS252222
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
K123926
Product Code
JDR
Product Code Name
STAPLE, FIXATION, BONE
Public Device Record Key
412ea080-bbeb-43f3-bfb5-47aa5b1cf4b3
Public Version Date
November 23, 2021
Public Version Number
5
DI Record Publish Date
October 09, 2017
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 | 1909 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1404 |
| 3 | A medical device with high risk that requires premarket approval | 12 |
| U | Unclassified | 15 |