Catalog Number

08-0840-014

Brand Name

Panama™

Version/Model Number

Panama™

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K210182

Product Code

KWQ

Product Code Name

Appliance, Fixation, Spinal Intervertebral Body

Public Device Record Key

95bfce0f-a9a4-4547-91e6-db6c2f3f13a4

Public Version Date

September 09, 2021

Public Version Number

1

DI Record Publish Date

September 01, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-