Globus Medical INDEPENDENCE MIS® Interbody Fusion System. Catalog #3135.0715

Vendor/Manufacturer: Globus Medical

Product/Product Line: INDEPENDENCE MIS® Interbody Fusion System

Vendor/Manufacturer Catalog #: 3135.0715

Category 1: Spine

Category 2: Interbody Fusion Devices

Category 3: Lumbar/T-Lumbar

FDA Regulation Medical Specialty:

Orthopedic Devices - Prosthetic Devices

FDA Regulation Number: 888.3080

FDA Regulation Description Classification Name:

Intervertebral body fusion device

FDA Classification Product Code: OVD

FDA Classification Product Code Device Name:

Intervertebral Fusion Device With Integrated Fixation, Lumbar

FDA Premarket Submissions: K160597

The Globus Medical INDEPENDENCE MIS® Interbody Fusion System is

SUBSTANTIALLY EQUIVALENT to the following product(s):

1. ROI-A Implant System

2. STALIF TT

3. Brigade Hyperlordotic System

4. INDEPENDENCE® Spacers

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