Duns Number:783908713
Device Description: ASTRA-OCT Dia. 3.5mm CoCr Z-Rod, 9mm Offset, 325mm
Catalog Number
A3ZR-359-325K
Brand Name
ASTRA-OCT Spine System
Version/Model Number
A3ZR-359-325K
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"
Yes
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
K181350
Product Code
KWP
Product Code Name
APPLIANCE, FIXATION, SPINAL INTERLAMINAL
Public Device Record Key
7e42015c-5f53-4e16-ba88-4b2cabb3c256
Public Version Date
November 05, 2018
Public Version Number
1
DI Record Publish Date
October 03, 2018
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 | 1247 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 15504 |