Duns Number:602465783
Device Description: 4.0mm Variable Angle, Self-Drilling Screw, Single Lead 16mm
Catalog Number
-
Brand Name
Insignia
Version/Model Number
236-1-24016
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
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
K213443
Product Code
KWQ
Product Code Name
Appliance, fixation, spinal intervertebral body
Public Device Record Key
06382647-9ce5-4c7a-acdf-079a723b6dc4
Public Version Date
March 18, 2022
Public Version Number
1
DI Record Publish Date
March 10, 2022
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 | 5644 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 26570 |
| U | Unclassified | 15 |