FortiCore - FortiCore PLIF Trial 12x12x32 (6°) - NANOVIS SPINE, LLC

Duns Number:079898044

Device Description: FortiCore PLIF Trial 12x12x32 (6°)

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More Product Details

Catalog Number

10498-3212

Brand Name

FortiCore

Version/Model Number

10498-3212

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

-

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 Details

Product Code

MAX

Product Code Name

Intervertebral Fusion Device With Bone Graft, Lumbar

Device Record Status

Public Device Record Key

6e89ffd6-9793-47cc-b8da-c0aca22bda3b

Public Version Date

February 24, 2020

Public Version Number

2

DI Record Publish Date

October 04, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NANOVIS SPINE, LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 540