Duns Number:600505107
Device Description: OSSIOfiber® Compression Screw, 4.0X54 mm. Package contains: 1 Implant.
Catalog Number
OF1024054S
Brand Name
OSSIOfiber® Compression Screw
Version/Model Number
OF1024054S
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
K193660
Product Code
HWC
Product Code Name
Screw, Fixation, Bone
Public Device Record Key
d8756be3-3e10-4f50-af06-600f225cc344
Public Version Date
June 28, 2021
Public Version Number
1
DI Record Publish Date
June 20, 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 | 10 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 42 |