Catalog Number

SW19159-2212

Brand Name

Stronghold® 3D Titanium Interbody Device System

Version/Model Number

SW19159-2212

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

K180990

Product Code

MAX

Product Code Name

Intervertebral Fusion Device With Bone Graft, Lumbar

Public Device Record Key

b6669ed4-1276-47cf-95b0-8dc001066750

Public Version Date

August 10, 2021

Public Version Number

1

DI Record Publish Date

August 02, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-