Catalog Number

-

Brand Name

Inertia® Pedicle Screw and Deformity Correxxion® System

Version/Model Number

10-22-9565

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K153453

Product Code

KWP

Product Code Name

Appliance, Fixation, Spinal Interlaminal

Public Device Record Key

16e541d0-8b7d-4757-ae3f-6f71429b48b4

Public Version Date

May 27, 2019

Public Version Number

1

DI Record Publish Date

May 17, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-