Duns Number:146060863
Device Description: Clamp Assembly Size Ø4.5 mm Rail / Ø6.0 Clamp Assembly Size Ø4.5 mm Rail / Ø6.0 mm
Catalog Number
5401-84500H-G2
Brand Name
NILE™ Alternative Fixation System
Version/Model Number
5401-84500H-G2
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
K160208
Product Code
OWI
Product Code Name
Bone fixation cerclage, sublaminar
Public Device Record Key
7d79bf08-238f-4908-992f-14f73e53377d
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
June 16, 2016
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 | 5699 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 17961 |