Duns Number:942377524
Device Description: The Integra TruArch subtalar implant is a one-piece titanium implant for treating hyperpro The Integra TruArch subtalar implant is a one-piece titanium implant for treating hyperpronation of the foot. It is designed to block forward, downward and medial displacement of the talus, thus allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela. The implant is offered in 5 sizes ranging from 8mm to 12mm in diameter. The system includes instruments to facilitate the placement of the implants.
Catalog Number
TRUARCHIMP
Brand Name
Integra® TruArch®
Version/Model Number
TRUARCHIMP
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
-
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
K111265
Product Code
HWC
Product Code Name
Screw, fixation, bone
Public Device Record Key
a42acb4c-2758-4574-b964-226d2bcca2b7
Public Version Date
July 16, 2020
Public Version Number
4
DI Record Publish Date
September 22, 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 | 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 |