Duns Number:942377524
Device Description: The Integra Total Foot System interpositioning plate is used to space apart two bones or a The Integra Total Foot System interpositioning plate is used to space apart two bones or a joint. The plate is anatomically T-shaped with increased width and stem depth for ease of insertion and less intraoperative contouring required.
Catalog Number
2802112
Brand Name
Integra® Total Foot System
Version/Model Number
2802112
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
K100502,K123000
Product Code
HRS
Product Code Name
PLATE, FIXATION, BONE
Public Device Record Key
76d95e50-d440-4b8d-beda-35478a5de704
Public Version Date
July 06, 2018
Public Version Number
3
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 |