restor3d Kinos Axiom PSR

Basic Information

• Brand Name: restor3d Kinos Axiom PSR
• Primary DI: 00840097509945
• Version / Model: 5831-9006
• Company Name: Restor3d, Inc.
• Labeler DUNS: 080819836
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-09-27
• Public Version: 2
• Public Version Date: 2023-11-02
• Public Version Status: Update
• Public Device Record Key: be3c5440-e981-4b6c-bf97-ac07d226408b

Device Description

Axiom coupled PSR, Flat-cut

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: Yes
• 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
OYK	Ankle Arthroplasty Implantation System	Orthopedic	888.3110	2

GMDN Terms

Code	Name	Definition	Implantable	Status
65079	Osteotomy guide, single-use	A surgical instrument intended to be attached to a bone (e.g., pelvis, femur, tibia, ulna) during an osteotomy procedure (including during joint arthroplasty) to outline/define the desired cut-line and mechanically support/guide the cutting device (e.g., oscillating cutting saw). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840097509945	GS1

Premarket Submissions

Submission Number	Supplement Number
K223326	000