Catalog Number

-

Brand Name

MySpine

Version/Model Number

7.0554

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K153273

Product Code

MNI

Product Code Name

Orthosis, Spinal Pedicle Fixation

Public Device Record Key

c88178e4-026c-4ff3-ab70-fbccc78297c9

Public Version Date

January 21, 2021

Public Version Number

1

DI Record Publish Date

January 13, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-