Catalog Number

67-C-1715-12-10L

Brand Name

Fortilink Cages with TiPlus Technology

Version/Model Number

Fortilink®-C

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

Yes

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K201453

Product Code

ODP

Product Code Name

Intervertebral Fusion Device With Bone Graft, Cervical

Public Device Record Key

4ec20ebc-c28e-422b-bf0f-51ebd34f51c9

Public Version Date

December 01, 2021

Public Version Number

1

DI Record Publish Date

November 23, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-