GEO Bone Screw System

GUDID B471102081050

Bone Screw 8x105 Headless Short Thread Cannulated Ti

GRAMERCY EXTREMITY ORTHOPEDICS LLC

Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile

• Primary Device ID: B471102081050
• NIH Device Record Key: cf95ee6a-91d3-4d4d-b305-5d745029532e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GEO Bone Screw System
• Version Model Number: 10208105
• Company DUNS: 080068420
• Company Name: GRAMERCY EXTREMITY ORTHOPEDICS LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(855)436-2278
• Email: GEOSupportCenter@gramercyortho
• Phone: +1(855)436-2278
• Email: GEOSupportCenter@gramercyortho

Device Dimensions

• Outer Diameter: 8 Millimeter
• Length: 105 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 105 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B471102081050 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161904

FDA Product Code

• HWC: Screw, fixation, bone

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-11-12
• Device Publish Date: 2018-10-10

On-Brand Devices [GEO Bone Screw System]

• B471712800060: Washer Pack (2) for 8mm Bone Screw
• B471712800050: Washer Pack (2) for 7mm Bone Screw
• B471712800040: Washer Pack (2) for 5mm Bone Screw
• B471712800030: Washer Pack (2) for 4mm Bone Screw
• B471712800020: Washer Pack (2) for 3mm Bone Screw
• B471712800010: Washer Pack (2) for 2mm Bone Screw
• B471711300060: K-Wire Pack (2) 2.5mmx230mm for 7mm/8mm Bone Screw
• B471711300050: K-Wire Pack (2) 2.5mmx150mm for 7mm/8mm Bone Screw
• B471711300040: K-Wire Pack (2) 1.6mmx150mm for 4mm/5mm Bone Screw
• B471711300030: K-Wire Pack (2) 1.6mmx100mm for 4mm/5mm Bone Screw
• B471711300020: K-Wire Pack (2) 1.2mmx100mm for 3mm Bone Screw
• B471711300010: K-Wire Pack (2) 0.9mmx100mm for 2mm Bone Screw
• B471701000130: Instrument Kit for 7mm/8mm Bone Screw, 230mm K-Wire
• B471701000120: Instrument Kit for 7mm/8mm Bone Screw, 150mm K-Wire
• B471701000070: Instrument Kit for 4mm/5mm Bone Screw
• B471701000020: Instrument Kit for 3mm Bone Screw
• B471701000010: Instrument Kit for 2mm Bone Screw
• B471280000080: Washer for 8mm Bone Screw
• B471280000070: Washer for 7mm Bone Screw
• B471280000050: Washer for 5mm Bone Screw
• B471280000040: Washer for 4mm Bone Screw
• B471280000030: Washer for 3mm Bone Screw
• B471280000020: Washer for 2mm Bone Screw
• B471270101500: Depth Gauge for 100mm/150mm K-Wires
• B471270002300: Depth Gauge for 230mm Guide Wire
• B471270001000: Depth Gauge for 100mm K-Wire
• B471231000910: Countersink Tip 7mm/8mm Bone Screw Hudson
• B471230000660: Countersink Tip 4mm/5mm Bone Screw AO
• B471230000410: Countersink Tip 2mm/3mm Bone Screw AO
• B471212502300: Drill Bit 5.0mmx230mm ZH Cannulated
• B471212501600: Drill Bit 5.0mmx160mm ZH Cannulated
• B471210281500: Drill Bit 2.8mmx150mm AO Cannulated
• B471210281000: Drill Bit 2.8mmx100mm AO Cannulated
• B471210201000: Drill Bit 2.0mmx100mm AO Cannulated
• B471201910000: Driver Handle Hudson Ratchet Straight Reusable
• B471201099300: Driver Tip Hexalobe T-30 Hudson SS
• B471201099200: Driver Tip Hexalobe T-20 Hudson SS
• B471200920000: Driver Handle AO Fixed Spinner Straight Reusable
• B471200099200: Driver Tip Hexalobe T-20 AO SS
• B471200099100: Driver Tip Hexalobe T-10 AO SS
• B471200099080: Driver Tip Hexalobe T-8 AO SS
• B471132252300: K-Wire 2.5mmx230mm Single Threaded Tip
• B471132251500: K-Wire 2.5mmx150mm Single Threaded Tip
• B471132161500: K-Wire 1.6mmx150mm Single Threaded Tip
• B471132161000: K-Wire 1.6mmx100mm Single Threaded Tip
• B471131091000: K-Wire 0.9mmx100mm Double Smooth Tip
• B471130252300: K-Wire 2.5mmx230mm Single Smooth Tip
• B471130251500: K-Wire 2.5mmx150mm Single Smooth Tip
• B471130161500: K-Wire 1.6mmx150mm Single Smooth Tip
• B471130161000: K-Wire 1.6mmx100mm Single Smooth Tip