Duns Number:071595540
Device Description: T50S65 TenoLok Tenodesis Kit with 5.0 mm TenoLok Anchor with One No. 2 Hi-Fi Suture, 2.4 m T50S65 TenoLok Tenodesis Kit with 5.0 mm TenoLok Anchor with One No. 2 Hi-Fi Suture, 2.4 mm Guide Pin, and 6.5 mm Drill Bit
Catalog Number
T50S65
Brand Name
TENOLOK
Version/Model Number
T50S65
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
K120841
Product Code
MBI
Product Code Name
Fastener, fixation, nondegradable, soft tissue
Public Device Record Key
3f335660-8051-419e-b924-335c6ac71361
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 27, 2016
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 |