Duns Number:071595540
Device Description: CrossFT Knotless SDT 5.5 mm Suture Anchor with #2 Hi-Fi Suture
Catalog Number
CFK-55SDT
Brand Name
ConMed
Version/Model Number
CFK-55SDT
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
K163258
Product Code
MBI
Product Code Name
Fastener, fixation, nondegradable, soft tissue
Public Device Record Key
ea207d6d-b65d-4d33-9539-470422ed0ae4
Public Version Date
March 21, 2019
Public Version Number
3
DI Record Publish Date
August 17, 2018
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 |