Duns Number:063692935
Device Description: The CoNextions TR Tendon Repair System consists of a single-use, sterile implant consistin The CoNextions TR Tendon Repair System consists of a single-use, sterile implant consistingof two identical stainless steel anchors implanted in either end of the injured tendon andconnected by two loops of UHMWPE fiber. The implant is provided pre-loaded into an ImplantMechanism and with a Deployment Mechanism to facilitate placement.
Catalog Number
FA0001
Brand Name
CoNextions TR Tendon Repair System-Combo Kit
Version/Model Number
FA0001
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
K203855,K203855
Product Code
GAQ
Product Code Name
Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
Public Device Record Key
e8e54a3f-9cdb-4929-b474-b6be61952a6e
Public Version Date
May 06, 2022
Public Version Number
1
DI Record Publish Date
April 28, 2022
Package DI Number
10861445000300
Quantity per Package
10
Contains DI Package
00861445000303
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
10-Pack
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |