Duns Number:146060863
Device Description: Transitional Rod, Size Ø4.0-4.5 mm x300 mm Ti
Catalog Number
7601-540300-45
Brand Name
YUKON OCT Spinal System
Version/Model Number
7601-540300-45
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
K182182
Product Code
KWP
Product Code Name
APPLIANCE, FIXATION, SPINAL INTERLAMINAL
Public Device Record Key
02eb81a4-8969-4c12-b688-59caea49d097
Public Version Date
April 08, 2019
Public Version Number
1
DI Record Publish Date
March 29, 2019
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 |