Duns Number:003489810
Device Description: SA ALIF, 30x40 Trial Caddy
Catalog Number
-
Brand Name
NEXXT MATRIXX® Stand Alone ALIF System
Version/Model Number
C61-02-03
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
-
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
K202230
Product Code
OVD
Product Code Name
Intervertebral Fusion Device With Integrated Fixation, Lumbar
Public Device Record Key
2ba3a03c-0a49-4a1e-8899-d8f19bae8eb7
Public Version Date
August 10, 2021
Public Version Number
3
DI Record Publish Date
February 24, 2021
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 | 1102 |
2 | A medical device with a moderate to high risk that requires special controls. | 4259 |
U | Unclassified | 91 |