QUANTUM M05 00771

GUDID 03701337600778

QUANTUM Impaction Frame Tibial Implant

IN2BONES USA, LLC

Orthopaedic implant impactor, reusable

• Primary Device ID: 03701337600778
• NIH Device Record Key: 8e276a68-e7f5-4334-90c6-d40aabcdc687
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QUANTUM
• Version Model Number: M05 00771
• Catalog Number: M05 00771
• Company DUNS: 079700711
• Company Name: IN2BONES USA, LLC
• 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: true
• 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: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	03701337600778 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191380

FDA Product Code

• FZX: Guide, surgical, instrument

Sterilization

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

[03701337600778]

Moist Heat or Steam Sterilization

[03701337600778]

Moist Heat or Steam Sterilization

[03701337600778]

Moist Heat or Steam Sterilization

[03701337600778]

Moist Heat or Steam Sterilization

[03701337600778]

Moist Heat or Steam Sterilization

[03701337600778]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-12-23
• Device Publish Date: 2024-12-13

On-Brand Devices [QUANTUM]

• 03701337617967: QUANTUM IMPACTOR FRAME QUICK COUPLING
• 03701337601096: QUANTUM Pin Pusher
• 03701337600808: QUANTUM Shaper For Tibial Stem
• 03701337600792: QUANTUM Handle For Impaction Frame
• 03701337600778: QUANTUM Impaction Frame Tibial Implant