Avenger Modular Radial Head Implant

GUDID 00817906028881

Stem Component, Standard 8.5 mm

IN2BONES USA, LLC

Elbow radius prosthesis

• Primary Device ID: 00817906028881
• NIH Device Record Key: cdf57821-31a9-4187-b1b9-e44e38943edc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Avenger Modular Radial Head Implant
• Version Model Number: M70 SC085
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817906028881 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192754

FDA Product Code

• KWI: Prosthesis, Elbow, Hemi-, Radial, Polymer

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-03-02
• Device Publish Date: 2020-02-21

On-Brand Devices [Avenger Modular Radial Head Implant]

• 00817906028942: Stem Component, Long 9.5 mm
• 00817906028935: Stem Component, Long 8.5 mm
• 00817906028928: Stem Component, Long 7.5 mm
• 00817906028911: Stem Component, Long 6.5 mm
• 00817906028904: Stem Component, Long 5.5 mm
• 00817906028898: Stem Component, Standard 9.5 mm
• 00817906028881: Stem Component, Standard 8.5 mm
• 00817906028874: Stem Component, Standard 7.5 mm
• 00817906028867: Stem Component, Standard 6.5 mm
• 00817906028850: Stem Component, Standard 5.5 mm
• 00817906028843: Head Component, +4 24 mm
• 00817906028836: Head Component, +2 24 mm
• 00817906028829: Head Component, 24 mm
• 00817906028812: Head Component, +4 22 mm
• 00817906028805: Head Component, +2 22 mm
• 00817906028799: Head Component, 22 mm
• 00817906028782: Head Component, +4 20 mm
• 00817906028775: Head Component, +2 20 mm
• 00817906028768: Head Component, 20 mm
• 00817906028751: Head Component, +4 18 mm
• 00817906028744: Head Component, +2 18 mm
• 00817906028737: Head Component, 18 mm