FX V 135 stem 318-5616

GUDID 03701037317969

FX V135 STEM TA6V Ø40/16 LG 120MM CEMENTLESS Ti/HA

FX SOLUTIONS

Coated shoulder humeral stem prosthesis

• Primary Device ID: 03701037317969
• NIH Device Record Key: 613087aa-099e-4f07-8f67-0d8c1badc84b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FX V 135 stem
• Version Model Number: 318-5616
• Catalog Number: 318-5616
• 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	03701037317969 [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