Catalog Number

-

Brand Name

Horizon Subtalar Complete Kit

Version/Model Number

22797

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K041936

Product Code

LXH

Product Code Name

Orthopedic Manual Surgical Instrument

Public Device Record Key

464a26a9-f49e-4bfb-820a-dc7bc8edd867

Public Version Date

October 01, 2020

Public Version Number

1

DI Record Publish Date

September 23, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-