Catalog Number

-

Brand Name

SFS;SFS LE;SFS SCOLI

Version/Model Number

59-4770

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"

Yes

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

K080407

Product Code

MNI

Product Code Name

Orthosis, spinal pedicle fixation

Public Device Record Key

90e1d90a-f701-4b07-9639-dd911369e233

Public Version Date

March 27, 2019

Public Version Number

1

DI Record Publish Date

March 19, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-