Duns Number:772462123
Device Description: The SoftLink™ Titanium Button w/Adjustable UHMWPE Loop device consists of an adjustable no The SoftLink™ Titanium Button w/Adjustable UHMWPE Loop device consists of an adjustable nonabsorbable braided loop and titanium button, preloaded with traction threads, designed to be used for ACL reconstruction. The implant is supplied sterile, ready to use.
Catalog Number
16-10420
Brand Name
SoftLink™
Version/Model Number
Titanium Button w/Adjustable UHMWPE Loop - cortical tunnel = Ø 5 to 10 mm
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 09, 2020
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
-
Product Code
MBI
Product Code Name
Fastener, Fixation, Nondegradable, Soft Tissue
Public Device Record Key
24094270-5269-4419-b8b2-7f1c0b218075
Public Version Date
November 16, 2020
Public Version Number
6
DI Record Publish Date
April 20, 2017
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 259 |