Duns Number:600505107
Device Description: The OSSIOfiber® Hammertoe Fixation Implant, M, 2.9X19 mm, angled 10°. Package contains: 1 The OSSIOfiber® Hammertoe Fixation Implant, M, 2.9X19 mm, angled 10°. Package contains: 1 Inserter, 1 Implant angled 10°.
Catalog Number
OF10029191
Brand Name
OSSIOfiber® Hammertoe Fixation Implant
Version/Model Number
OF10029191
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
K190652
Product Code
HTY
Product Code Name
Pin, Fixation, Smooth
Public Device Record Key
529215ef-56ad-4b5f-8610-23bf3ec110b2
Public Version Date
March 20, 2020
Public Version Number
1
DI Record Publish Date
March 12, 2020
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 |