Duns Number:080819836
Device Description: Titanium (Ti-6Al-4V) Subtalar Wedge, Right Foot, Large Footprint, 12mm Thickness, 10 Degre Titanium (Ti-6Al-4V) Subtalar Wedge, Right Foot, Large Footprint, 12mm Thickness, 10 Degree
Catalog Number
-
Brand Name
restor3d Utility Wedge
Version/Model Number
1105-2723121005R
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K201314
Product Code
PLF
Product Code Name
Bone Wedge
Public Device Record Key
50fea6ad-da7a-4f3c-9c72-60485fd6250c
Public Version Date
April 04, 2022
Public Version Number
1
DI Record Publish Date
March 25, 2022
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 | 156 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 156 |