Duns Number:592616445
Device Description: Intended to be used for the preparation and pre-tensioning of single tendon grafts for lig Intended to be used for the preparation and pre-tensioning of single tendon grafts for ligament reconstruction.
Catalog Number
72205270
Brand Name
X-Wing Base
Version/Model Number
72205270
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LXH
Product Code Name
Orthopedic Manual Surgical Instrument
Public Device Record Key
6d9a5937-7d67-421c-9cad-a5175c53eb7b
Public Version Date
December 08, 2020
Public Version Number
1
DI Record Publish Date
November 30, 2020
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 | 107 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7 |