Duns Number:945518848
Device Description: Side Plate, 135 Deg x 38mm, Standard Barrel, 3 Hole
Catalog Number
-
Brand Name
Talon™ Compression Hip Screw System
Version/Model Number
THS135383
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
K984331
Product Code
HWC
Product Code Name
Screw, Fixation, Bone
Public Device Record Key
92c84207-0bfe-4a61-8373-e9045ec071c2
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 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 | 14 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 200 |