INBONE™ BIOFOAM™ 3D

GUDID 00889797073004

WRIGHT MEDICAL TECHNOLOGY, INC.

Fixed-bearing total ankle prosthesis Fixed-bearing total ankle prosthesis Fixed-bearing total ankle prosthesis Fixed-bearing total ankle prosthesis Fixed-bearing total ankle prosthesis Fixed-bearing total ankle prosthesis

• Primary Device ID: 00889797073004
• NIH Device Record Key: 39cbcfc7-2057-40aa-ab35-d25b3e8b9767
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INBONE™ BIOFOAM™ 3D
• Version Model Number: 220221901
• Company DUNS: 807201207
• Company Name: WRIGHT MEDICAL TECHNOLOGY, INC.
• 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: true
• 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

Customer Support Contacts

• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889797073004 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191393

FDA Product Code

• HSN: PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-04-22
• Device Publish Date: 2020-04-14

On-Brand Devices [INBONE™ BIOFOAM™ 3D]

• 00889797073042: 220221905
• 00889797073035: 220221904
• 00889797073028: 220221903
• 00889797073011: 220221902
• 00889797073004: 220221901