Orbitum Staple System

Basic Information

• Brand Name: Orbitum Staple System
• Primary DI: B565FO2002200
• Version / Model: Rev A
• Catalog Number: FO-2002-20
• Company Name: CPM MEDICAL CONSULTANTS, LLC
• Labeler DUNS: 017138000
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-04-16
• Public Version: 1
• Public Version Date: 2021-04-26
• Public Version Status: New
• Public Device Record Key: 9c57d3d9-7a17-418a-8c3c-817d1fefcc3d

Device Description

20mm Inserter

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
JDR	Staple, Fixation, Bone	Orthopedic	888.3030	2

GMDN Terms

Code	Name	Definition	Implantable	Status
10458	Orthopaedic bone staple driver	A hand-held surgical instrument designed to impart force on a bone staple, or on another instrument, to insert the bone staple typically into fractured bone. The distal end is typically shaped to mate with the bone staple. The proximal end is designed to absorb and transmit an impact force. It is typically made of high-grade stainless steel or titanium (Ti). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B565FO2002200	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K173693	000