Catalog Number

106-07

Brand Name

SpineNet SSP®

Version/Model Number

SpineNet SSP® Fixed Drill Guide

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

-

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

K200170

Product Code

KWQ

Product Code Name

Appliance, Fixation, Spinal Intervertebral Body

Public Device Record Key

0928276d-de63-4c3b-9748-f54a72b214ad

Public Version Date

January 20, 2022

Public Version Number

1

DI Record Publish Date

January 12, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-