Duns Number:063692935
Device Description: The Coronet Soft Tissue Fixation System consists of a single-use, sterile implant used tof The Coronet Soft Tissue Fixation System consists of a single-use, sterile implant used tofixate tissue to bone and tissue to tissue. The implant consists of an anchor and soft tissuewasher interconnected via a continuous loop of suture. The implant comes pre-assembled toan inserter, which facilitates concurrent placement of the anchor and soft tissue washer. Adrill bit is provided to allow for the creation of a properly sized pilot hole in the boneimplantation site.
Catalog Number
FA01025
Brand Name
Coronet
Version/Model Number
FA01025
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
K200028,K200028
Product Code
HTN
Product Code Name
Washer, Bolt Nut
Public Device Record Key
e1dd5b2d-28de-4795-8538-877b9428bbc3
Public Version Date
July 08, 2020
Public Version Number
1
DI Record Publish Date
June 30, 2020
Package DI Number
10861445000331
Quantity per Package
10
Contains DI Package
00861445000334
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 |