Duns Number:024163331
Device Description: The long bone plates are made of titanium alloy, are provided in standard and low profile
Catalog Number
TO-CLP-LBP-200
Brand Name
WOLF Curved Low Profile Plate, 200mm, 15 Hole
Version/Model Number
NA
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
K131834
Product Code
HRS
Product Code Name
Plate, Fixation, Bone
Public Device Record Key
2752ef4b-f69f-42ba-b9de-f1e78d4903db
Public Version Date
August 24, 2020
Public Version Number
1
DI Record Publish Date
August 15, 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 | 41 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 112 |