Navigated Instrument System

Basic Information

• Brand Name: Navigated Instrument System
• Primary DI: 00840019942935
• Version / Model: 70-BK-0109
• Catalog Number: 70-BK-0109
• Company Name: PRECISION SPINE, INC.
• Labeler DUNS: 079398589
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-03-08
• Public Version: 1
• Public Version Date: 2023-03-16
• Public Version Status: New
• Public Device Record Key: e615dfa9-2bc2-4222-8dfb-3a8d1ca3c01d

Device Description

Reform Ti CT Modular MIS Navigated Instrument Kit

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
OLO	Orthopedic Stereotaxic Instrument	Neurology	882.4560	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44054	Orthopaedic surgical procedure kit, non-medicated, reusable	A collection of various orthopaedic surgical instruments, dressings and the necessary materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840019942935	GS1

Premarket Submissions

Submission Number	Supplement Number
K181606	000