Catalog Number

-

Brand Name

CALCANEAL DROP-IN TRAY

Version/Model Number

9947-000

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

K182466

Product Code

HRS

Product Code Name

Plate, Fixation, Bone

Public Device Record Key

c1b01d9f-237d-47c4-b3e0-6d23cdcec670

Public Version Date

September 16, 2022

Public Version Number

5

DI Record Publish Date

June 16, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-