FX V 135 humeral spacer 203-0007

GUDID 03701037315453

FX V 135 HUMERAL SPACER TA6V +9mm

FX SOLUTIONS

Coated shoulder humeral stem prosthesis Coated shoulder humeral stem prosthesis Coated shoulder humeral stem prosthesis Coated shoulder humeral stem prosthesis Coated shoulder humeral stem prosthesis

• Primary Device ID: 03701037315453
• NIH Device Record Key: 69df12f4-7a35-4e6f-a93d-0a44b0b47801
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FX V 135 humeral spacer
• Version Model Number: 203-0007
• Catalog Number: 203-0007
• Company DUNS: 263076196
• Company Name: FX SOLUTIONS
• 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: true
• Serial Number: false
• Manufacturing Date: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	03701037315453 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213117

FDA Product Code

• PHX: Shoulder Prosthesis, Reverse Configuration

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: 2022-06-21
• Device Publish Date: 2022-06-10

Devices Manufactured by FX SOLUTIONS

• 03701037318966 - FX V135 Shoulder Prosthesis: 2024-04-29 INLAY CUP HOLE SAW Ø36mm
• 03701037318973 - FX V135 Shoulder Prosthesis: 2024-04-29 FX V135 PLATE FOR CUPULAR ROLE SAW
• 03701037319147 - Humeris Shoulder: 2024-04-03 Graft Clamp for 3-4 pegs glenoid
• 03701037320389 - FX V135 Shoulder Prosthesis: 2024-04-03 Glenoid Manual Reamer Ø40mm
• 03701037320396 - FX V135 Shoulder Prosthesis: 2024-04-03 Glenoid Manual Reamer Ø36mm
• 03701037301043 - Humelock II Cementless Shoulder System: 2024-03-06 HUMELOCK II STEM TA6V SIZE 10 CEMENTLESS TI/HA
• 03701037310588 - Humeral Cup Standard: 2024-03-06 HUMERAL CUP 135/145° STANDARD PE/TA6V Ø32 +3
• 03701037309476 - Humelock Reversed System: 2024-03-05 HUMELOCK REVERSED CENTERED GLENOSPHERE W/ SCREW CoCr/TA6V 10° TILT Ø32mm