Catalog Number

490-4520

Brand Name

Rampart One Lumbar Interbody Fusion Device

Version/Model Number

10-10-75-2

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

MRI safety Status

MR Unsafe

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

K163670

Product Code

OVD

Product Code Name

Intervertebral fusion device with integrated fixation, lumbar

Public Device Record Key

d4e1ee8f-04da-4f75-9e4c-baf4c75acd21

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

May 19, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-