Additive Orthopaedic Bone Wedge System

Basic Information

• Brand Name: Additive Orthopaedic Bone Wedge System
• Primary DI: 00850005508014
• Version / Model: AOEW-18-10
• Company Name: ADDITIVE ORTHOPAEDICS LLC
• Labeler DUNS: 085503457
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-03-04
• Public Version: 2
• Public Version Date: 2021-06-08
• Public Version Status: Update
• Public Device Record Key: c4f02531-2316-44c3-a5d5-b0528a853d21

Device Description

Evans Bone Segment - 18x18x10

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: Yes
• 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
HRS	Plate, Fixation, Bone	Orthopedic	888.3030	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61617	Metallic osteotomy fusion cage, non-customized	A non-customized device intended to be implanted between the severed ends of a long bone (e.g., femur, tibia), or other bone (e.g., tarsal, carpel), following osteotomy to help facilitate bone fusion and alignment; it may be used with a plating fixation system and may be used in association with a bone substitute/graft. The device is typically designed as a small, wedge-shaped cylinder (or other geometric form) and is made of metal [e.g., titanium (Ti)].	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850005508014	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K153207	000