Catalog Number

-

Brand Name

COMET Lumbar Interbody Fusion Cage

Version/Model Number

595-15308

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K191353

Product Code

MAX

Product Code Name

Intervertebral Fusion Device With Bone Graft, Lumbar

Public Device Record Key

a0e4bb7a-dde3-48aa-9d1f-b0c7be9890c3

Public Version Date

October 14, 2020

Public Version Number

1

DI Record Publish Date

October 06, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-