Kinos Axiom Instrumentation

Basic Information

• Brand Name: Kinos Axiom Instrumentation
• Primary DI: 00840097508900
• Version / Model: 5801-4109
• Catalog Number: 5801.4109
• Company Name: Restor3d, Inc.
• Labeler DUNS: 080819836
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-07-19
• Public Version: 2
• Public Version Date: 2023-11-02
• Public Version Status: Update
• Public Device Record Key: ba06ff21-93c1-42bb-aa7e-f4e012df5250

Device Description

50.5 mm x 1.21 mm Reciprocating Blade

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
HSN	Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer	Orthopedic	888.3110	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44742	Joint prosthesis implantation kit, reusable	A collection of surgical instruments used for cutting and forming bone to allow the implantation of a joint prosthesis. The instruments include various metallic and/or plastic reusable devices (e.g., retractors, rods, clamps, drills, pins, saws, guides, cutting blocks) that are specific to the joint of application (e.g., hip, knee, shoulder, ankle, or elbow); 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	00840097508900	GS1

Premarket Submissions

Submission Number	Supplement Number
K192778	000