Catalog Number

4508-41F66

Brand Name

CAYMAN® Plate System-MI

Version/Model Number

4508-41F66

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K131533

Product Code

KWQ

Product Code Name

Appliance, fixation, spinal intervertebral body

Public Device Record Key

97abe63f-0406-4c62-b390-ca58c70db77f

Public Version Date

March 11, 2019

Public Version Number

1

DI Record Publish Date

February 19, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-