Catalog Number

-

Brand Name

NeoFuse Ti3D PLIF/TLIF

Version/Model Number

C3212-18

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 13, 2022

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

K170318

Product Code

MAX

Product Code Name

Intervertebral Fusion Device With Bone Graft, Lumbar

Public Device Record Key

d7eb4626-48d2-426b-8ff2-2b8c3110cb74

Public Version Date

July 15, 2022

Public Version Number

6

DI Record Publish Date

November 07, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-