DePuy Synthes CONDUIT. Interbody Fusion Device. Cervical. Non-Bone. Catalog #CUI8070L

Vendor/Manufacturer: DePuy Synthes

Product/Product Line: CONDUIT Interbody Fusion Device

Vendor/Manufacturer Catalog #: CUI8070L

Global Unique Device (GUD) Primary Device Identifier Number:

04260557770665

Global Unique Device (GUD) Device Description:

EIT CIF cage, H 7mm, 8°, L

Global Medical Device Nomenclature (GMDN) Preferred Term Name:

Metallic 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: K170503

SUBSTANTIALLY EQUIVALENT to the following product(s):

1. Ortho Development Vusion CS+

2. Scient’X Tribeca Cage

3. CoAlign AccuLIF

4. 4Web PLIF STS, TLIF STS and OLIF STS (Spine Truss System)

5. Precision Spine ShurFit® PLIF Interbody Cage