Duns Number:071595540
Device Description: T60A80 TenoLok Tenodesis Kit with 6.0 mm TenoLok Anchor with One No. 2 Hi-Fi Suture, 2.4 m T60A80 TenoLok Tenodesis Kit with 6.0 mm TenoLok Anchor with One No. 2 Hi-Fi Suture, 2.4 mm Guide Pin, and 8.0 mm Drill Bit
Catalog Number
T60A80
Brand Name
TENOLOK
Version/Model Number
T60A80
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 03, 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
1ff10bd6-ef7b-4625-bdff-488368da480a
Public Version Date
February 03, 2021
Public Version Number
4
DI Record Publish Date
September 24, 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 |