PRCT II

GUDID 03701037302200

STANDARD SCREW TA6V Ø4.5mm L.18mm

FX SOLUTIONS

Orthopaedic bone screw (non-sliding)

• Primary Device ID: 03701037302200
• NIH Device Record Key: db0870e5-3604-44f2-a909-ceb348d3defd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PRCT II
• Version Model Number: 109-4518
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	03701037302200 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150488

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: 2024-08-14
• Device Publish Date: 2024-08-06

On-Brand Devices [PRCT II]

• 03701037302606: STANDARD SCREW TA6V Ø4.5mm L.42mm
• 03701037302590: STANDARD SCREW TA6V Ø4.5mm L.38mm
• 03701037302576: STANDARD SCREW TA6V Ø4.5mm L.34mm
• 03701037302286: STANDARD SCREW TA6V Ø4.5mm L.55mm
• 03701037302200: STANDARD SCREW TA6V Ø4.5mm L.18mm
• 03701037302194: STANDARD SCREW TA6V Ø4.5mm L.16mm
• 03701037302149: LOCKING SCREW TA6V Ø4.5mm L.55mm