FX V135 Shoulder Prosthesis

GUDID 03701037317167

OFFSET HEAD 50x18

FX SOLUTIONS

Stem-fixed humeral head prosthesis Stem-fixed humeral head prosthesis Stem-fixed humeral head prosthesis Stem-fixed humeral head prosthesis Stem-fixed humeral head prosthesis Stem-fixed humeral head prosthesis Stem-fixed humeral head prosthesis Stem-fixed humeral head prosthesis Stem-fixed humeral head prosthesis Stem-fixed humeral head prosthesis Stem-fixed humeral head prosthesis Stem-fixed humeral head prosthesis Stem-fixed humeral head prosthesis Stem-fixed humeral head prosthesis Stem-fixed humeral head prosthesis Stem-fixed humeral head prosthesis Stem-fixed humeral head prosthesis

• Primary Device ID: 03701037317167
• NIH Device Record Key: 5391d2cc-ae63-4057-9420-8601bf1c4f5f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FX V135 Shoulder Prosthesis
• Version Model Number: 206-5032
• 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	03701037317167 [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: 2024-01-31
• Device Publish Date: 2024-01-23

On-Brand Devices [FX V135 Shoulder Prosthesis]

• 03701037315408: 203-0906 FX V135 HUMERAL CUP 135/145° STABILITY PE/TA6V Ø36 +6
• 03701037315392: FX V135 HUMERAL CUP 135/145° STABILITY PE/TA6V Ø36 +3
• 03701037315385: FX V135 HUMERAL CUP 135/145° STABILITY PE/TA6V Ø32 +9
• 03701037315378: FX V135 HUMERAL CUP 135/145° STABILITY PE/TA6V Ø32 +6
• 03701037315361: FX V135 HUMERAL CUP 135/145° STABILITY PE/TA6V Ø32 +3
• 03701037315323: FX V135 HUMERAL CUP 135/145° STANDARD PE/TA6V Ø36 +9
• 03701037315316: FX V135 HUMERAL CUP 135/145° STANDARD PE/TA6V Ø36 +6
• 03701037315309: FX V135 HUMERAL CUP 135/145° STANDARD PE/TA6V Ø36 +3
• 03701037315293: FX V135 HUMERAL CUP 135/145° STANDARD PE/TA6V Ø32 +9
• 03701037315286: FX V135 HUMERAL CUP 135/145° STANDARD PE/TA6V Ø32 +6
• 03701037315279: FX V135 HUMERAL CUP 135/145° STANDARD PE/TA6V Ø32 +3
• 03701037317174: OFFSET HEAD 50x22
• 03701037317167: OFFSET HEAD 50x18
• 03701037317150: CENTERED HEAD 50x21
• 03701037317143: CENTERED HEAD 50x17
• 03701037317136: OFFSET HEAD 48x21
• 03701037317129: OFFSET HEAD 48x17
• 03701037317112: CENTERED HEAD 48x20
• 03701037317105: CENTERED HEAD 48x16
• 03701037317099: OFFSET HEAD 46x20
• 03701037317082: OFFSET HEAD 46x16
• 03701037317075: CENTERED HEAD 46x19
• 03701037317068: CENTERED HEAD 46x15
• 03701037317051: OFFSET HEAD 43x19
• 03701037317044: OFFSET HEAD 43x15
• 03701037317037: CENTERED HEAD 43x18
• 03701037317020: CENTERED HEAD 43x14
• 03701037317013: OFFSET HEAD 41x18
• 03701037317006: OFFSET HEAD 41x14
• 03701037316993: CENTERED HEAD 41x17
• 03701037316986: CENTERED HEAD 41x13
• 03701037316979: OFFSET HEAD 39x17
• 03701037316962: OFFSET HEAD 39x13
• 03701037316955: CENTERED HEAD 39x16
• 03701037316948: CENTERED HEAD 39x13
• 03701037315446: FX V135 HUMERAL CUP 135/145° STABILITY PE/TA6V Ø40 +9
• 03701037315439: FX V135 HUMERAL CUP 135/145° STABILITY PE/TA6V Ø40 +6
• 03701037315422: FX V135 HUMERAL CUP 135/145° STABILITY PE/TA6V Ø40 +3
• 03701037315415: FX V135 HUMERAL CUP 135/145° STABILITY PE/TA6V Ø36 +9
• 03701037315354: FX V135 HUMERAL CUP 135/145° STANDARD PE/TA6V Ø40 +9
• 03701037315347: FX V135 HUMERAL CUP 135/145° STANDARD PE/TA6V Ø40 +6
• 03701037315330: FX V135 HUMERAL CUP 135/145° STANDARD PE/TA6V Ø40 +3
• 03701037320396: Glenoid Manual Reamer Ø36mm
• 03701037320389: Glenoid Manual Reamer Ø40mm