Avenger Radial Head, +4 Stems

GUDID 00810021866383

Avenger Radial Head Stem Implant, Size Ø8.5 x 25 mm, +4mm

IN2BONES USA, LLC

Elbow radius prosthesis

• Primary Device ID: 00810021866383
• NIH Device Record Key: 73708e53-bc7f-4dd1-a3c0-3a4b47964e26
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Avenger Radial Head, +4 Stems
• Version Model Number: M70 SC385
• Company DUNS: 079700711
• Company Name: IN2BONES USA, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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	00810021866383 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212872

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: 2022-02-07
• Device Publish Date: 2022-01-28

On-Brand Devices [Avenger Radial Head, +4 Stems]

• 00810021866390: Avenger Radial Head Stem Implant, Size Ø9.5 x 25 mm, +4mm
• 00810021866383: Avenger Radial Head Stem Implant, Size Ø8.5 x 25 mm, +4mm
• 00810021866376: Avenger Radial Head Stem Implant, Size Ø7.5 x 25 mm, +4mm
• 00810021866369: Avenger Radial Head Stem Implant, Size Ø6.5 x 24 mm, +4mm
• 00810021866352: Avenger Radial Head Stem Implant, Size Ø5.5 x 24 mm, +4mm
• 00810021866345: Avenger Radial Head Stem Implant, Size Ø9.5 x 17 mm, +4mm
• 00810021866338: Avenger Radial Head Stem Implant, Size Ø8.5 x 17 mm, +4mm
• 00810021866321: Avenger Radial Head Stem Implant, Size Ø7.5 x 17 mm, +4mm
• 00810021866314: Avenger Radial Head Stem Implant, Size Ø6.5 x 16 mm, +4mm
• 00810021866307: Avenger Radial Head Stem Implant, Size Ø5.5 x 16 mm, +4mm