Duns Number:107105876
Device Description: ISOLA SPINE SYSTEM ASSEMBLY WITH CENTER NUT
Catalog Number
203080
Brand Name
ISOLA
Version/Model Number
203080
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 20, 2018
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
K980485
Product Code
KWP
Product Code Name
APPLIANCE, FIXATION, SPINAL INTERLAMINAL
Public Device Record Key
26e5dad4-7b8a-438f-9c03-398698ea4b0f
Public Version Date
July 06, 2018
Public Version Number
5
DI Record Publish Date
September 24, 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 | 5839 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2784 |
| U | Unclassified | 20 |