Duns Number:080300717
Device Description: 10mm or 12mm x 23mm Version B, 6 degree – Shim
Catalog Number
FHPA-S1-06-23-B
Brand Name
FlareHawk
Version/Model Number
II-1-0178
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 07, 2020
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
K160076
Product Code
MAX
Product Code Name
Intervertebral Fusion Device With Bone Graft, Lumbar
Public Device Record Key
5ae80485-c97c-4c63-b40f-131f95234106
Public Version Date
May 13, 2022
Public Version Number
6
DI Record Publish Date
January 30, 2017
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 | 787 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1255 |