PROPHECY INFINITY

GUDID 00889797057134

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 Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide 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: 00889797057134
• NIH Device Record Key: f6237cd7-64e9-4cba-877f-d9d687592f03
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PROPHECY INFINITY
• Version Model Number: PROPINF
• 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: 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
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00889797057134 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131283

FDA Product Code

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

Sterilization

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

[00889797057134]

Moist Heat or Steam Sterilization

[00889797057134]

Moist Heat or Steam Sterilization

[00889797057134]

Moist Heat or Steam Sterilization

[00889797057134]

Moist Heat or Steam Sterilization

[00889797057134]

Moist Heat or Steam Sterilization

[00889797057134]

Moist Heat or Steam Sterilization

[00889797057134]

Moist Heat or Steam Sterilization

[00889797057134]

Moist Heat or Steam Sterilization

[00889797057134]

Moist Heat or Steam Sterilization

[00889797057134]

Moist Heat or Steam Sterilization

[00889797057134]

Moist Heat or Steam Sterilization

[00889797057134]

Moist Heat or Steam Sterilization

[00889797057134]

Moist Heat or Steam Sterilization

[00889797057134]

Moist Heat or Steam Sterilization

[00889797057134]

Moist Heat or Steam Sterilization

[00889797057134]

Moist Heat or Steam Sterilization

[00889797057134]

Moist Heat or Steam Sterilization

[00889797057134]

Moist Heat or Steam Sterilization

[00889797057134]

Moist Heat or Steam Sterilization

[00889797057134]

Moist Heat or Steam Sterilization

[00889797057134]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-12-04
• Device Publish Date: 2016-10-27

On-Brand Devices [PROPHECY INFINITY]

• 00889797057134: PROPINF
• 00889797004879: 33600200
• 00889797103374: Tibial Resection Guide Insert
• 00889797102438: Reversible Talar Resection Guide
• 00889797102421: Tibial Corner Protector Peg
• 00889797102414: Tibial Resection Guide Insert
• 00889797102407: Tibial Resection Guide Insert
• 00889797102391: Tibial Resection Guide Insert