Catalog Number

PTLT4HR

Brand Name

Piccolo Composite Plate System

Version/Model Number

Proximal Tibia Template, Lateral, Right

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

-

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

0e3b1404-8afa-413a-bd6d-b6c6a27bb73f

Public Version Date

February 23, 2021

Public Version Number

1

DI Record Publish Date

February 15, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-