Duns Number:649185170
Device Description: Tibial Medial plate intended to buttress metaphyseal fractures of the medial tibia plateau Tibial Medial plate intended to buttress metaphyseal fractures of the medial tibia plateau, split-type fractures of the medial tibia plateau, medial split fractures with associated depressions and split or depression fractures of the medial tibia plateau. The plates may also be used for fixation of the proximal quarter (lateral and medial) of the tibia as well as segmental fractures of the proximal tibia.
Catalog Number
PTMR0010
Brand Name
Piccolo Composite Plate System
Version/Model Number
Tibial Medial Plate, 10 holes, Right
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
K201917
Product Code
HRS
Product Code Name
Plate, Fixation, Bone
Public Device Record Key
c3dc2fb9-24c2-42b2-8cf3-b89efa5723ab
Public Version Date
February 22, 2021
Public Version Number
1
DI Record Publish Date
February 14, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 1387 |