Catalog Number

1022-14151808

Brand Name

SureMAX-SA

Version/Model Number

1

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

K211111

Product Code

OVE

Product Code Name

Intervertebral Fusion Device With Integrated Fixation, Cervical

Public Device Record Key

f3c13dd3-50cc-44d4-899a-e7914ee4c63e

Public Version Date

October 08, 2021

Public Version Number

1

DI Record Publish Date

September 30, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-