Duns Number:486711679
Device Description: 3.5MM TI LCP® METAPHYSEAL PLATE 10 HOLES
Catalog Number
423410
Brand Name
LCP
Version/Model Number
423.410
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
K033805
Product Code
LXT
Product Code Name
APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT, METAL COMPOSITE
Public Device Record Key
8b09ec6e-107d-49c3-b2bb-5650f78adca9
Public Version Date
May 02, 2022
Public Version Number
4
DI Record Publish Date
September 14, 2015
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 | 8630 |
2 | A medical device with a moderate to high risk that requires special controls. | 16671 |
U | Unclassified | 2 |