Catalog Number

ZPSS5

Brand Name

WAVE Calcaneal Fracture Plate™

Version/Model Number

ZPSS5

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"

Yes

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

HRS

Product Code Name

PLATE, FIXATION, BONE

Public Device Record Key

2ee8b316-fe80-4823-9fca-40ef68ea8353

Public Version Date

March 28, 2022

Public Version Number

3

DI Record Publish Date

September 26, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-