Cervical Interbody Fusion Device

Basic Information

• Brand Name: Cervical Interbody Fusion Device
• Primary DI: B5651508N1
• Version / Model: 1508N
• Catalog Number: 1508N
• Company Name: Maxim Surgical
• Labeler DUNS: 012241561
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-07-21
• Public Version: 4
• Public Version Date: 2020-02-24
• Public Version Status: Update
• Public Device Record Key: 12428679-37be-4331-8215-ffe6399c4dd7

Device Description

PEEK Cervical Spacer 15x13x8 mm Neutral

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: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

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
60762	Polymeric spinal interbody fusion cage	A device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is in the form of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical device made of non-bioabsorbable synthetic polymer [e.g., polyetheretherketone (PEEK)] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be included with the device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B5651508N1	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K123206	000

Device Sizes

Type	Value	Unit	Text
Height	8	Millimeter
Width	13	Millimeter
Length	15	Millimeter