Duns Number:600505107
Device Description: OSSIOfiber® Suture Anchor 4.75 mm with Needles, Black Tape, Blue/White & #2 Suture. Packag OSSIOfiber® Suture Anchor 4.75 mm with Needles, Black Tape, Blue/White & #2 Suture. Package contains: 1 Implant, 1 Inserter, 1 Black 1.8mm Suture Tape, 1 Blue/White Round #2 Suture, 4 Stainless Steel MO-6 Needles.
Catalog Number
OF1034752S
Brand Name
OSSIOfiber® Suture Anchor
Version/Model Number
OF1034752S
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"
-
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
K213415
Product Code
MAI
Product Code Name
Fastener, Fixation, Biodegradable, Soft Tissue
Public Device Record Key
56dcdddb-9ee0-4ac5-b9e6-ea9ca93013e4
Public Version Date
June 14, 2022
Public Version Number
1
DI Record Publish Date
June 06, 2022
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 |