PROPHECY™ INFINITY™ PROPINFF

GUDID 00889797102353

WRIGHT MEDICAL TECHNOLOGY, INC.

Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide

• Primary Device ID: 00889797102353
• NIH Device Record Key: a17e4f73-6aa1-4513-95f3-b3ad88009463
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PROPHECY™ INFINITY™
• Version Model Number: PROPINFF
• Catalog Number: PROPINFF
• 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: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889797102353 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202815

FDA Product Code

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

Sterilization

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

[00889797102353]

Moist Heat or Steam Sterilization

[00889797102353]

Moist Heat or Steam Sterilization

[00889797102353]

Moist Heat or Steam Sterilization

[00889797102353]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-06-02
• Device Publish Date: 2022-05-25

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