Catalog Number

STGC-LCS30.25

Brand Name

C-VBR

Version/Model Number

Lordotic-S-30.25

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 08, 2018

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

K152568

Product Code

PLR

Product Code Name

Spinal vertebral body replacement device - Cervical

Public Device Record Key

409c8a56-9bde-4234-a721-9b24a4cb60b7

Public Version Date

February 24, 2020

Public Version Number

4

DI Record Publish Date

March 26, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-