Catalog Number

-

Brand Name

My Spine S2-Alar/Alar-Iliac Pedicle Screw Placement Guides

Version/Model Number

7.0707S

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

K200792

Product Code

PQC

Product Code Name

Pedicle Screw Placement Guide

Public Device Record Key

c804e728-305c-4586-abff-4fc1c2faa24d

Public Version Date

October 16, 2020

Public Version Number

1

DI Record Publish Date

October 08, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-