ALEUTIAN® Interbody Systems

Basic Information

• Brand Name: ALEUTIAN® Interbody Systems
• Primary DI: 10888857488151
• Version / Model: SP-4206-03
• Catalog Number: SP-4206-03
• Company Name: K2M, INC.
• Labeler DUNS: 146060863
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-11-23
• Public Version: 1
• Public Version Date: 2020-12-01
• Public Version Status: New
• Public Device Record Key: c752cbde-00b2-46c9-b4af-eb973b7753c3

Device Description

Trial, Size 14x14.5x7 mm, 7°

Device Characteristics

• Single Use: No
• 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
MQP	Spinal vertebral body replacement device	Orthopedic	888.3060	2
MAX	Intervertebral fusion device with bone graft, lumbar	Orthopedic	888.3080	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44759	General internal orthopaedic fixation system implantation kit	A collection of instruments and devices intended to be used for the placement of an internal orthopaedic fixation system into or onto all types of bones (e.g., bones of limbs, spine, pelvis, or craniomaxillofacial). It is a non-dedicated device that includes various metallic and/or plastic reusable devices [e.g., retractors, rods, clamps, drills, pins, saws, screwdrivers, guides, trials, impactors] intended to be used for the implantation of any type of internal orthopaedic fixation system; the implant(s) is not included. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10888857488151	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K133614	000

Device Sizes

Type	Value	Unit	Text
Height	7	Millimeter
Width	14.5	Millimeter
Angle	7	degree
Length	14	Millimeter