Vendor/Manufacturer: DePuy Synthes
Product/Product Line: ACIS Interbody Fusion Device
Vendor/Manufacturer Catalog #: 108843007
Global Unique Device (GUD) Primary Device Identifier Number:
00819917020427
Global Unique Device (GUD) Device Description:
NA
Global Medical Device Nomenclature (GMDN) Preferred Term Name:
Metal-polymer composite spinal interbody fusion cage
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: ODP
FDA Classification Product Code Device Name:
Intervertebral Fusion Device With Bone Graft, Cervical
Category 1: Spine
Category 2: Interbody Fusion Devices
Category 3: Cervical
Category 4: Non-Bone
FDA Premarket Submissions: K172185
SUBSTANTIALLY EQUIVALENT to the following product(s):
Comentarios