AFX™

GUDID M543CM2410AP1

AFX™ Femoral Implant - 10mm x 24mm

CAYENNE MEDICAL, INC.

Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile

• Primary Device ID: M543CM2410AP1
• NIH Device Record Key: 5a2c12dd-9d50-4060-8082-7b899c35dfc4
• Commercial Distribution Discontinuation: 2023-04-11
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: AFX™
• Version Model Number: CM-2410AP
• Company DUNS: 606719685
• Company Name: CAYENNE MEDICAL, INC.
• 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
HIBCC	M543CM2410AP1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161033

FDA Product Code

• MBI: Fastener, Fixation, Nondegradable, Soft Tissue

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2023-09-13
• Device Publish Date: 2017-01-05

On-Brand Devices [AFX™]

• M543CM2410AP1: AFX™ Femoral Implant - 10mm x 24mm
• M543CM2409AP1: AFX™ Femoral Implant 9mm x 24mm