IGNITE™ 2.0 876P0080

GUDID 00889797076029

WRIGHT MEDICAL TECHNOLOGY, INC.

Bone matrix implant, human-derived

• Primary Device ID: 00889797076029
• NIH Device Record Key: f795e325-22fd-4b85-afd0-bf8d6bfd6572
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IGNITE™ 2.0
• Version Model Number: 876P0080
• Catalog Number: 876P0080
• Company DUNS: 807201207
• Company Name: WRIGHT MEDICAL TECHNOLOGY, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: true
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• 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
• 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
• 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

• Total Volume: 8 Milliliter
• Total Volume: 8 Milliliter
• Total Volume: 8 Milliliter
• Total Volume: 8 Milliliter
• Total Volume: 8 Milliliter
• Total Volume: 8 Milliliter
• Total Volume: 8 Milliliter
• Total Volume: 8 Milliliter
• Total Volume: 8 Milliliter
• Total Volume: 8 Milliliter
• Total Volume: 8 Milliliter
• Total Volume: 8 Milliliter
• Total Volume: 8 Milliliter
• Total Volume: 8 Milliliter
• Total Volume: 8 Milliliter
• Total Volume: 8 Milliliter

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889797076029 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190482

FDA Product Code

• MQV: FILLER, BONE VOID, CALCIUM COMPOUND

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: 2022-03-04
• Device Publish Date: 2022-02-24

Devices Manufactured by WRIGHT MEDICAL TECHNOLOGY, INC.

• 00889797113465 - N/A: 2025-02-26 Pilot Drill
• 00889797113472 - N/A: 2025-02-26 Inbone Cut Block
• 00889797104579 - N/A: 2024-12-03 Screwdriver
• 00889797104159 - N/A: 2024-10-21 Procedure Pack Sterile
• 00889797109802 - N/A: 2024-10-15 SOLO™ Proximal Guide Block
• 00889797109819 - N/A: 2024-10-15 SOLO™ Corner Removal Guide
• 00889797103923 - PROstep MIS: 2024-09-23 Chamfer Screw
• 00889797106351 - Made-To-Order: 2024-09-11 Swanson Toe Grommet Seater