Catalog Number

222245

Brand Name

ORTHOCORD HEALIX TI

Version/Model Number

222245

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

K082282

Product Code

HWC

Product Code Name

Screw, fixation, bone

Public Device Record Key

ed365e9d-98a7-48b3-8ecc-2e0a14cd4faa

Public Version Date

March 21, 2019

Public Version Number

5

DI Record Publish Date

September 01, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-