Inserter/Extractor CIA-001

GUDID 10855068008348

Reusable surgical instrument used to engage the proximal end of the flexible CurvaFix® IM Implant in preparation for insertion into the intramedullary canal for implantation. If needed, device can also be used to engage the implant during a removal procedure.

Curvafix Inc

Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable

• Primary Device ID: 10855068008348
• NIH Device Record Key: 3210424a-7b95-4f03-8c66-57cb1be966df
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Inserter/Extractor
• Version Model Number: CIA-001
• Catalog Number: CIA-001
• 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• 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
• Phone: 425-276-8800
• Email: support@curvafix.com
• Phone: 425-276-8800
• Email: support@curvafix.com
• Phone: 425-276-8800
• Email: support@curvafix.com
• Phone: 425-276-8800
• Email: support@curvafix.com
• Phone: 425-276-8800
• Email: support@curvafix.com
• Phone: 425-276-8800
• Email: support@curvafix.com
• Phone: 425-276-8800
• Email: support@curvafix.com
• Phone: 425-276-8800
• Email: support@curvafix.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10855068008348 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180050

FDA Product Code

• HSB: Rod, Fixation, Intramedullary And Accessories

Sterilization

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

[10855068008348]

Moist Heat or Steam Sterilization

[10855068008348]

Moist Heat or Steam Sterilization

[10855068008348]

Moist Heat or Steam Sterilization

[10855068008348]

Moist Heat or Steam Sterilization

[10855068008348]

Moist Heat or Steam Sterilization

[10855068008348]

Moist Heat or Steam Sterilization

[10855068008348]

Moist Heat or Steam Sterilization

[10855068008348]

Moist Heat or Steam Sterilization

[10855068008348]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-08-19
• Device Publish Date: 2021-08-11

On-Brand Devices [Inserter/Extractor]

• 10855068008348: Reusable surgical instrument used to engage the proximal end of the flexible CurvaFix® IM Impla
• 10855068008492: Reusable surgical instrument used to engage the proximal end of the flexible CurvaFix® IM Impla