Addivation Medical Cervical Interbody Device

Basic Information

• Brand Name: Addivation Medical Cervical Interbody Device
• Primary DI: B804AOCS61201
• Version / Model: AOCS6120
• Company Name: ADDIVATION MEDICAL, LLC
• Labeler DUNS: 117239290
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-06-03
• Public Version: 1
• Public Version Date: 2020-06-11
• Public Version Status: New
• Public Device Record Key: 68369c82-432e-4be5-b77c-5c5bd13ca0ae

Device Description

Cervical Spine Interbody Device. 12 x 14mm footprint, 10mm height, 6 degrees lordosis.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	888.3080	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47139	Spinal fusion sphere	A sterile implantable metal sphere used to stabilize interspinous processes from L3 to S1 to promote intervertebral body fusion. It is inserted into the disc space between two vertebral bodies, and is specifically designed to be used with a bone graft to hold the bones in alignment while they heal and fuse. The device is typically made of a high-grade medical cobalt-chrome (Co-Cr) or Cobalt-Chrome-Molybdenum (Co-Cr-Mo).	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B804AOCS61201	HIBCC

Premarket Submissions

Submission Number	Supplement Number
K190291	000