Instrument Set (case and Reusable Instruments) CIS-004

GUDID 10855068008737

A custom engineered set of reusable surgical instruments, housed in a sterilizable storage container, that are used during a CurvaFix surgical procedure.

Curvafix Inc

Orthopaedic surgical procedure kit, non-medicated, reusable

• Primary Device ID: 10855068008737
• NIH Device Record Key: c201b832-3da4-414c-9b11-a56d838c8984
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Instrument Set (case and Reusable Instruments)
• Version Model Number: CIS-004
• Catalog Number: CIS-004
• Company DUNS: 039779098
• Company Name: Curvafix 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 425-276-8800
• Email: support@curvafix.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10855068008737 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222505

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

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

[10855068008737]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-01-13
• Device Publish Date: 2023-01-05

On-Brand Devices [Instrument Set (case and Reusable Instruments)]

• 10855068008522: A custom engineered set of reusable surgical instruments, housed in a sterilizable storage conta
• 10855068008737: A custom engineered set of reusable surgical instruments, housed in a sterilizable storage conta