GTFx™ Greater Tuberosity Fracture Plate System SO03-3151

GUDID 00815482021005

GTF Guide Plate, Right

Shoulder Options, Inc.

Orthopaedic implant aiming/guiding block, reusable Orthopaedic implant aiming/guiding block, reusable Orthopaedic implant aiming/guiding block, reusable

• Primary Device ID: 00815482021005
• NIH Device Record Key: fac66d25-7a18-494f-91f5-016dcbc1717a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GTFx™ Greater Tuberosity Fracture Plate System
• Version Model Number: SO03-3151
• Catalog Number: SO03-3151
• Company DUNS: 053545528
• Company Name: Shoulder Options, Inc.
• Device Count: 1
• DM Exempt: true
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• 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: 704-512-0000
• Email: burgan@shoulderoptions.com
• Phone: 704-512-0000
• Email: burgan@shoulderoptions.com
• Phone: 704-512-0000
• Email: burgan@shoulderoptions.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815482021005 [Primary]

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

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

[00815482021005]

Moist Heat or Steam Sterilization

[00815482021005]

Moist Heat or Steam Sterilization

[00815482021005]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2015-11-02

On-Brand Devices [GTFx™ Greater Tuberosity Fracture Plate System]

• 00815482021012: GTF Guide Handle
• 00815482021005: GTF Guide Plate, Right
• 00815482020992: GTF Guide Plate, Left
• 00815482020985: GTF Plate, Right
• 00815482020978: GTF Plate, Left