Duns Number:600505107
Device Description: The OSSIOfiber™ Hammertoe Fixation Implant is indicated for maintenance of alignment and The OSSIOfiber™ Hammertoe Fixation Implant is indicated for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodesis, and bone grafts in the presence of appropriate additional immobilization (e.g. rigid fixation implants, cast, brace).
Catalog Number
OF10129190
Brand Name
OSSIOfiber™ Hammertoe Fixation Implant
Version/Model Number
2.9X19 mm straight
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
K181180
Product Code
HTY
Product Code Name
Pin, Fixation, Smooth
Public Device Record Key
78d7e0f8-765f-42dc-be01-d21b0d98c6b5
Public Version Date
April 23, 2019
Public Version Number
1
DI Record Publish Date
April 15, 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 | 10 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 42 |