Fortuna MIS eX-TAB Stabilization System - 5.5mm x 35mm MIS eX-TAB Screw, Cannulated - OSSO SURGICAL LLC

Duns Number:081363044

Device Description: 5.5mm x 35mm MIS eX-TAB Screw, Cannulated

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More Product Details

Catalog Number

-

Brand Name

Fortuna MIS eX-TAB Stabilization System

Version/Model Number

211-55035-1

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

K162576

Product Code Details

Product Code

MNH

Product Code Name

Orthosis, Spondylolisthesis Spinal Fixation

Device Record Status

Public Device Record Key

c17a99da-e5ee-4f33-a578-f4ed43ecf34e

Public Version Date

September 24, 2020

Public Version Number

1

DI Record Publish Date

September 16, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"OSSO SURGICAL LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 75