Duns Number:927083808
Device Description: FORZA - INSTRUMENT TRAY (89-0021)
Catalog Number
89-0021
Brand Name
FORZA
Version/Model Number
450367-0002
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
-
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
K172437
Product Code
MAX
Product Code Name
Intervertebral fusion device with bone graft, lumbar
Public Device Record Key
d072d3b0-9e27-471a-9951-a3e6b0240698
Public Version Date
February 24, 2020
Public Version Number
2
DI Record Publish Date
March 12, 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 | 2497 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 5891 |
| 3 | A medical device with high risk that requires premarket approval | 104 |