Bead Extractor, 8.0 mm RKG-001

GUDID 10855068008867

A hand-held surgical instrument with a cannulated stainless steel shaft and an aluminum handle used over a wire to grab and extract a loose 9.5mm CurvaFix Implant Main Body Bead using sharp flutes on the inside of the head of the instrument.

Curvafix Inc

Orthopaedic implant inserter/extractor, reusable

• Primary Device ID: 10855068008867
• NIH Device Record Key: 17384017-015c-4d27-880b-7d08928a4ea6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bead Extractor, 8.0 mm
• Version Model Number: RKG-001
• Catalog Number: RKG-001
• Company DUNS: 039779098
• Company Name: Curvafix Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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
• 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
• 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	10855068008867 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[10855068008867]

Moist Heat or Steam Sterilization

[10855068008867]

Moist Heat or Steam Sterilization

[10855068008867]

Moist Heat or Steam Sterilization

[10855068008867]

Moist Heat or Steam Sterilization

[10855068008867]

Moist Heat or Steam Sterilization

[10855068008867]

Moist Heat or Steam Sterilization

[10855068008867]

Moist Heat or Steam Sterilization

[10855068008867]

Moist Heat or Steam Sterilization

[10855068008867]

Moist Heat or Steam Sterilization

[10855068008867]

Moist Heat or Steam Sterilization

[10855068008867]

Moist Heat or Steam Sterilization

[10855068008867]

Moist Heat or Steam Sterilization

[10855068008867]

Moist Heat or Steam Sterilization

[10855068008867]

Moist Heat or Steam Sterilization

[10855068008867]

Moist Heat or Steam Sterilization

[10855068008867]

Moist Heat or Steam Sterilization

[10855068008867]

Moist Heat or Steam Sterilization

[10855068008867]

Moist Heat or Steam Sterilization

[10855068008867]

Moist Heat or Steam Sterilization

[10855068008867]

Moist Heat or Steam Sterilization

[10855068008867]

Moist Heat or Steam Sterilization

[10855068008867]

Moist Heat or Steam Sterilization

[10855068008867]

Moist Heat or Steam Sterilization

[10855068008867]

Moist Heat or Steam Sterilization

[10855068008867]

Moist Heat or Steam Sterilization

[10855068008867]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-10-04
• Device Publish Date: 2023-09-26

Devices Manufactured by Curvafix Inc

• 10855068008126 - Drill Wire Kit: 2024-12-13 A single use kit, composed of a sterile packaged Drill Wire and Exchange Tube, that is used during a surgical procedure for the
• 10855068008744 - Removal Drill, 9.5mm: 2023-10-04 A cannulated drill bit that attaches to a surgical power tool. It is used over a guide pin to remove bone leading up to or cover
• 10855068008751 - Removal Drill, 13.0 mm: 2023-10-04 A cannulated drill bit that attaches to a surgical power tool. It is used over a guide pin to remove bone leading up to or cover
• 10855068008768 - Tissue Sleeve, Removal Tool: 2023-10-04 A hand-held stainless steel tube used during a CurvaFix Implant removal to maintain direct access to the Implant head and protec
• 10855068008782 - Pin Sleeve, Removal Tool: 2023-10-04 A hand-held stainless steel tube used during a CurvaFix Implant removal that fits inside the Tissue Sleeve and contains a conica
• 10855068008829 - Removal Tool Set: 2023-10-04 A custom engineered set of reusable surgical instruments, housed in a sterilizable storage container, that are used to remove a
• 10855068008836 - Sterilization Case, Removal Tool Set: 2023-10-04 A reusable instrument storage case that can house and retain the reusable instruments of the Removal Tool Set during sterilizati
• 10855068008843 - Removal Coring Tool, Proximal Head: 2023-10-04 A T-handled cutting instrument with a cannula used over a wire to manually remove bone in a cylindral shape around the proximal