GEO Bone Screw System

Basic Information

• Brand Name: GEO Bone Screw System
• Primary DI: B471230000660
• Version / Model: 23000066
• Company Name: GRAMERCY EXTREMITY ORTHOPEDICS LLC
• Labeler DUNS: 080068420
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-10-10
• Public Version: 1
• Public Version Date: 2018-11-12
• Public Version Status: New
• Public Device Record Key: ccb634fc-d6c6-4b2d-b1d4-c0f96e8c22d4

Device Description

Countersink Tip 4mm/5mm Bone Screw AO

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: Yes
• Has Lot/Batch Number: No
• 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
HWW	COUNTERSINK	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47634	Surgical countersink, single-use	A rotary surgical instrument designed to enlarge the diameter of the proximal portion of a hole drilled in bone. It is a shaft of metal with a cutting head, available in various configurations, that is rotated at low speeds typically by a drilling system. The device is typically used to recess the head of a screw/bolt within bone (enable it to lie flush with or below the bone surface) or to help accommodate the implantation of a device in bone. This is a single-use device intended to be sterilized prior to use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B471230000660	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K161904	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -10 – 55 Degrees Celsius