Catalog Number

48291485S

Brand Name

GIZA

Version/Model Number

Corpectomy implant Giza, Diam 14 mm, 18-22 mm, 5-8 Deg

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

K112429

Product Code

MQP

Product Code Name

Spinal Vertebral Body Replacement Device

Public Device Record Key

a57ff8f5-9258-47a7-9053-bf48b8a0ad66

Public Version Date

February 24, 2020

Public Version Number

4

DI Record Publish Date

September 24, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-