Nextra CH

GUDID 00817701026303

Cannulated Hammertoe Mini Middle 4.25mm

Medartis 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 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: 00817701026303
• NIH Device Record Key: 2befe07c-950a-4344-963f-f9add11fad37
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nextra CH
• Version Model Number: CH-M425M
• Company DUNS: 192756786
• Company Name: Medartis 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: true
• 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	00817701026303 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200840

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2022-11-28
• Device Publish Date: 2020-11-11

On-Brand Devices [Nextra CH]

• 00817701026464: Cannulated Hammertoe Retriever
• 00817701026389: Cannulated Hammertoe Mini Instrument Kit
• 00817701026372: Cannulated Hammertoe Standard Instrument Kit
• 00817701026334: Cannulated Hammertoe Middle 5.0mm
• 00817701026327: Cannulated Hammertoe Middle 4.25mm
• 00817701026310: Cannulated Hammertoe Middle 3.5mm
• 00817701026303: Cannulated Hammertoe Mini Middle 4.25mm
• 00817701026297: Cannulated Hammertoe Mini Middle 3.5mm
• 00817701026280: Cannulated Hammertoe Mini Middle 2.75mm
• 00817701026273: Cannulated Hammertoe Mini Proximal 2.75mm
• 00817701026266: Cannulated Hammertoe Proximal 4.2mm
• 00817701026259: Cannulated Hammertoe Proximal 3.2mm