Duns Number:942377524
Device Description: The Integra Ti6 Internal Fixation System is comprised of Low Profile screws used for bone The Integra Ti6 Internal Fixation System is comprised of Low Profile screws used for bone fixation of the hand and foot following trauma or osteotomy. The low profile screw is a cannulated, threaded bone screw which is offered in 2.0, 2.5, 3.0 and 4.0 diameters with lengths of 2.0, 2.5, 3.0, and 4.0. The system includes titanium and stainless steel instruments to facilitate the placement of the screws.
Catalog Number
TI6LOPROIMP
Brand Name
Integra® Ti6® Internal Fixation System
Version/Model Number
TI6LOPROIMP
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
K060026
Product Code
HWC
Product Code Name
Screw, fixation, bone
Public Device Record Key
9152a170-2329-42b2-8c3f-1cda732d74df
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 |