Duns Number:649185170
Device Description: A plate indicated for the fixation of various long bones, such as the humerus, femur and t A plate indicated for the fixation of various long bones, such as the humerus, femur and tibia, including osteopenic bone, osteotomies, and nonunions or malunions in adult patients.
Catalog Number
PLCNN4509
Brand Name
Piccolo Composite Plate System
Version/Model Number
Diaphyseal Plate - Narrow
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
K102597,K130061
Product Code
HRS
Product Code Name
Plate, Fixation, Bone
Public Device Record Key
f3bc4787-a975-400e-9bf1-babe92756363
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 18, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 1387 |