DePuy Synthes ACIS. Interbody Fusion Device. Cervical. Non-Bone. Catalog #108843007

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):

1. Tyber Medical Interbody Spacer System

2. Synthes ACIS

3. DePuy Spine Concorde Curve

4. DePuy Spine Lateral System

5. Aesculap ASpace

6. Aesculap CESpace

7. Aesculap Prospace

8. Aesculap T-Space