Catalog Number

-

Brand Name

Calcaneus Plate Tack/Support Pin

Version/Model Number

PTK 400

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

-

Product Code

HXI

Product Code Name

Passer, Wire, Orthopedic

Public Device Record Key

2c48ee63-db0d-4b9c-82ac-d17e46cfc9a0

Public Version Date

September 16, 2022

Public Version Number

2

DI Record Publish Date

February 26, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-