Duns Number:328420633
Device Description: LOQTEQ® Dist. Lateral Femur Plate 4.5, 7/17 holes, L 386, L Titanium
Catalog Number
PF 4511-17-2
Brand Name
LOQTEQ®
Version/Model Number
PF 4511-17-2
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
K210043
Product Code
HRS
Product Code Name
Plate, Fixation, Bone
Public Device Record Key
86b9b014-861a-40d6-8a81-9a3a627fd314
Public Version Date
March 18, 2021
Public Version Number
1
DI Record Publish Date
March 10, 2021
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 | 738 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2701 |