Duns Number:942377524
Device Description: The Headed Compression Screw System contains compression screws used with the Ankle Fusion The Headed Compression Screw System contains compression screws used with the Ankle Fusion Plating System. This set includes screws with diamter 6.5mm or 7.5mm.
Catalog Number
HEADHNDSET
Brand Name
Integra Stainless Headed Compression Screw System
Version/Model Number
HEADHNDSET
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
K100176
Product Code
HRS
Product Code Name
PLATE, FIXATION, BONE
Public Device Record Key
9562543b-76b5-447e-b31c-21346620b7d6
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 |