FX V 135 stem 318-2021

GUDID 03701037318508

FX V135 LONG STEM TA6V CEMENTLESS Ø36/12 LG200mm Ti/HA

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 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 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 Coated shoulder humeral stem prosthesis Coated shoulder humeral stem prosthesis

• Primary Device ID: 03701037318508
• NIH Device Record Key: 1c99c08a-1867-4629-a716-1684e0c9921c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FX V 135 stem
• Version Model Number: 318-2021
• Catalog Number: 318-2021
• 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	03701037318508 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223801

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: 2023-06-23
• Device Publish Date: 2023-06-15

On-Brand Devices [FX V 135 stem]

• 03701037315262: FX V 135 stem TA6V Ø40/20 cementless Ti/HA
• 03701037315255: FX V 135 stem TA6V Ø40/18 cementless Ti/HA
• 03701037315248: FX V 135 stem TA6V Ø40/16 cementless Ti/HA
• 03701037315231: FX V 135 stem TA6V Ø40/14 cementless Ti/HA
• 03701037315224: FX V 135 stem TA6V Ø40/12 cementless Ti/HA
• 03701037315217: FX V 135 stem TA6V Ø36/18 cementless Ti/HA
• 03701037315200: FX V 135 stem TA6V Ø36/16 cementless Ti/HA
• 03701037315194: FX V 135 stem TA6V Ø36/14 cementless Ti/HA
• 03701037315187: FX V 135 stem TA6V Ø36/12 cementless Ti/HA
• 03701037315170: FX V 135 stem TA6V Ø36/10 cementless Ti/HA
• 03701037315163: FX V 135 stem TA6V Ø32/16 cementless Ti/HA
• 03701037315156: FX V 135 stem TA6V Ø32/14 cementless Ti/HA
• 03701037315149: FX V 135 stem TA6V Ø32/12 cementless Ti/HA
• 03701037315132: FX V 135 stem TA6V Ø32/10 cementless Ti/HA
• 03701037315125: FX V 135 stem TA6V Ø32/08 cementless Ti/HA
• 03701037318515: FX V135 LONG STEM TA6V CEMENTLESS Ø40/14 LG200mm Ti/HA
• 03701037318508: FX V135 LONG STEM TA6V CEMENTLESS Ø36/12 LG200mm Ti/HA
• 03701037318492: FX V135 LONG STEM TA6V CEMENTLESS Ø36/10 LG200mm Ti/HA
• 03701037318485: FX V135 LONG STEM TA6V CEMENTLESS Ø32/09 LG200mm Ti/HA
• 03701037318478: FX V135 LONG STEM TA6V CEMENTLESS Ø32/08 LG200mm Ti/HA
• 03701037318461: FX V135 LONG STEM TA6V CEMENTLESS Ø40/14 LG180mm Ti/HA
• 03701037318454: FX V135 LONG STEM TA6V CEMENTLESS Ø36/12 LG180mm Ti/HA
• 03701037318447: FX V135 LONG STEM TA6V CEMENTLESS Ø36/10 LG180mm Ti/HA
• 03701037318430: FX V135 LONG STEM TA6V CEMENTLESS Ø32/09 LG180mm Ti/HA
• 03701037318423: FX V135 LONG STEM TA6V CEMENTLESS Ø32/08 LG180mm Ti/HA
• 03701037317969: FX V135 STEM TA6V Ø40/16 LG 120MM CEMENTLESS Ti/HA
• 03701037317952: FX V135 STEM TA6V Ø40/14 LG 120MM CEMENTLESS Ti/HA
• 03701037317945: FX V135 STEM TA6V Ø40/12 LG 120MM CEMENTLESS Ti/HA
• 03701037317938: FX V135 STEM TA6V Ø36/14 LG 120MM CEMENTLESS Ti/HA
• 03701037317921: FX V135 STEM TA6V Ø36/12 LG 120MM CEMENTLESS Ti/HA
• 03701037317914: FX V135 STEM TA6V Ø36/10 LG 120MM CEMENTLESS Ti/HA
• 03701037317907: FX V135 STEM TA6V Ø32/12 LG 120MM CEMENTLESS Ti/HA
• 03701037317891: FX V135 STEM TA6V Ø32/10 LG 120MM CEMENTLESS Ti/HA
• 03701037317884: FX V135 STEM TA6V Ø32/08 LG 120MM CEMENTLESS Ti/HA