Catalog Number

P99-191-TX20-16

Brand Name

Phantom Hindfoot TTC/TC Nail System

Version/Model Number

P99-191-TX20-16

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

K201227

Product Code

HSB

Product Code Name

ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Public Device Record Key

345d7f9b-74b5-4f7c-980e-09d56e3f049b

Public Version Date

December 23, 2020

Public Version Number

1

DI Record Publish Date

December 15, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-