Duns Number:796416191
Device Description: 110° X 3.5MM INFANT PLATE, 2-HOLE, 6MM OFFSET
Catalog Number
00-0907-0142
Brand Name
Locking Proximal Femur Plate System
Version/Model Number
00-0907-0142
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K111086
Product Code
HRS
Product Code Name
Plate, fixation, bone
Public Device Record Key
9aa10b3f-f10a-43a1-a0b1-29ff86ea3b97
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
July 30, 2016
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 | 1662 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7273 |