IGNITE 2.0 876P0200

GUDID 00889797076036

Power Mix

WRIGHT MEDICAL TECHNOLOGY, INC.

Bone matrix implant, human-derived Bone matrix implant, human-derived Bone matrix implant, human-derived Bone matrix implant, human-derived Bone matrix implant, human-derived Bone matrix implant, human-derived Bone matrix implant, human-derived Bone matrix implant, human-derived Bone matrix implant, human-derived Bone matrix implant, human-derived Bone matrix implant, human-derived Bone matrix implant, human-derived Bone matrix implant, human-derived Bone matrix implant, human-derived

• Primary Device ID: 00889797076036
• NIH Device Record Key: 7cff0194-ffee-4eb7-b277-38e33004fab1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IGNITE 2.0
• Version Model Number: 876P0200
• Catalog Number: 876P0200
• 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

Device Dimensions

• Total Volume: 20 Milliliter
• Total Volume: 20 Milliliter
• Total Volume: 20 Milliliter
• Total Volume: 20 Milliliter
• Total Volume: 20 Milliliter
• Total Volume: 20 Milliliter
• Total Volume: 20 Milliliter
• Total Volume: 20 Milliliter
• Total Volume: 20 Milliliter
• Total Volume: 20 Milliliter
• Total Volume: 20 Milliliter
• Total Volume: 20 Milliliter
• Total Volume: 20 Milliliter
• Total Volume: 20 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889797076036 [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: 2022-08-31
• Device Publish Date: 2022-08-23

Devices Manufactured by WRIGHT MEDICAL TECHNOLOGY, INC.

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• 00889797102407 - Prophecy Infinity: 2024-04-18 Tibial Resection Guide Insert
• 00889797102414 - Prophecy Infinity: 2024-04-18 Tibial Resection Guide Insert
• 00889797102421 - Prophecy Infinity: 2024-04-18 Tibial Corner Protector Peg
• 00889797102438 - Prophecy Infinity: 2024-04-18 Reversible Talar Resection Guide
• 00889797103374 - Prophecy Infinity: 2024-04-18 Tibial Resection Guide Insert
• 00889797067218 - ORTHOLOC 3DI PLATING SYSTEM: 2024-02-19
• 00889797067225 - ORTHOLOC 3DI PLATING SYSTEM: 2024-02-19