Catalog Number

-

Brand Name

Salvo® Spine System

Version/Model Number

11-7457

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

K202476

Product Code

NKB

Product Code Name

Thoracolumbosacral Pedicle Screw System

Public Device Record Key

543f7cd5-2d8f-4276-affd-bdab25a0069c

Public Version Date

February 22, 2021

Public Version Number

1

DI Record Publish Date

February 12, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-