Catalog Number

-

Brand Name

RODIN

Version/Model Number

S.027.1011

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

K160646

Product Code

MQP

Product Code Name

Spinal vertebral body replacement device

Public Device Record Key

876f20a6-9602-4f1c-bb78-404ed587f680

Public Version Date

August 05, 2021

Public Version Number

1

DI Record Publish Date

July 28, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-