Duns Number:071595540
Device Description: Y-Knot® OneStep™ Anchor, One #2 Hi-Fi (Black)
Catalog Number
Y1S1K
Brand Name
Y-Knot, OneStep
Version/Model Number
Y1S1K
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 26, 2022
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
K193606
Product Code
MBI
Product Code Name
Fastener, fixation, nondegradable, soft tissue
Public Device Record Key
46d6c09e-9eef-4a00-a5e5-8a423cc7b6bc
Public Version Date
October 27, 2022
Public Version Number
2
DI Record Publish Date
August 21, 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 | 1412 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2261 |
| 3 | A medical device with high risk that requires premarket approval | 95 |