Catalog Number

-

Brand Name

MySpine

Version/Model Number

7.0730S

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

K220888

Product Code

PQC

Product Code Name

Pedicle Screw Placement Guide

Public Device Record Key

b8a9f3a6-314b-4788-9299-062fabb15a72

Public Version Date

June 07, 2022

Public Version Number

1

DI Record Publish Date

May 30, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-