Catalog Number

740-6540

Brand Name

Fortress Pedicale Screw

Version/Model Number

10-10-57-16

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

MRI safety Status

MR Unsafe

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

-

Product Code

MNH

Product Code Name

Orthosis, spondylolisthesis spinal fixation

Public Device Record Key

5d9a0997-1e28-4e7d-aecd-8198cf11ee06

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 17, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-