Catalog Number

STO-3-8090

Brand Name

Stowe Pedicle Screw System

Version/Model Number

STO-3-8090

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

K181554

Product Code

NKB

Product Code Name

Thoracolumbosacral pedicle screw system

Public Device Record Key

46f54c73-94ee-48a5-83ea-9adf5c71fce6

Public Version Date

June 21, 2021

Public Version Number

1

DI Record Publish Date

June 12, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-