Vendor/Manufacturer: Globus Medical
Product/Product Line: INDEPENDENCE MIS® Interbody Fusion System
Vendor/Manufacturer Catalog #: 1135.0025
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):
2. STALIF TT
For more information, please visit us at Infonomics.com
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