RR2501

GUDID 00889797102575

WRIGHT MEDICAL TECHNOLOGY, INC.

External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable External orthopaedic fixation system, reusable

• Primary Device ID: 00889797102575
• NIH Device Record Key: 376ee354-9cdc-4106-8950-82b64517e47f
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: RR2501
• Catalog Number: RR2501
• 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
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com

Device Dimensions

• Height: 2.5 Millimeter
• Height: 2.5 Millimeter
• Height: 2.5 Millimeter
• Height: 2.5 Millimeter
• Height: 2.5 Millimeter
• Height: 2.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889797102575 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K052005

FDA Product Code

• KTT: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Sterilization

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

[00889797102575]

Moist Heat or Steam Sterilization

[00889797102575]

Moist Heat or Steam Sterilization

[00889797102575]

Moist Heat or Steam Sterilization

[00889797102575]

Moist Heat or Steam Sterilization

[00889797102575]

Moist Heat or Steam Sterilization

[00889797102575]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-05-31
• Device Publish Date: 2022-05-23

Devices Manufactured by WRIGHT MEDICAL TECHNOLOGY, INC.

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• 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