Duns Number:536935331
Device Description: The TAC PIN is a self tapping threaded wire. Its proximal part is fixed on a standard surg The TAC PIN is a self tapping threaded wire. Its proximal part is fixed on a standard surgical power tool equipment and once the threaded wire is introduced and positioned as required, the surgeon cuts the protruding part at the bone surface. This pin is designed with a variable pitch, for a true and adapted compression. It is made out of titanium alloy, and it is delivered non sterile.
Catalog Number
120015ND
Brand Name
TAC PIN
Version/Model Number
120015ND
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 30, 2016
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"
Yes
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
-
Product Code
JDW
Product Code Name
PIN, FIXATION, THREADED
Public Device Record Key
cc4c07c3-ea8e-4e45-8695-3a15e5b3b849
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 24, 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 | 388 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 235 |