Duns Number:071595540
Device Description: 5.0 mm Tenolok Tenodesis Anchor with one No. 2 Hi-Fi Suture
Catalog Number
T50S
Brand Name
Tenolok
Version/Model Number
T50S
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 11, 2021
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
K120841
Product Code
MBI
Product Code Name
Fastener, fixation, nondegradable, soft tissue
Public Device Record Key
6b351705-e770-4470-be32-74d69d55e781
Public Version Date
February 11, 2021
Public Version Number
2
DI Record Publish Date
November 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 | 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 |