Catalog Number

9101-16

Brand Name

8 Degree Lordotic, Opticage Expandable Interbody Implant

Version/Model Number

9101-16

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 23, 2016

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

MAX

Product Code Name

Intervertebral Fusion Device With Bone Graft, Lumbar

Public Device Record Key

ac582c3f-2da4-4209-afe4-299f166d6de9

Public Version Date

February 24, 2020

Public Version Number

3

DI Record Publish Date

May 25, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-