RR180400

GUDID 00889797102698

WRIGHT MEDICAL TECHNOLOGY, INC.

External orthopaedic fixation system, reusable

• Primary Device ID: 00889797102698
• NIH Device Record Key: e94a24b5-5176-413e-943f-f116d95a841c
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: RR180400
• Catalog Number: RR180400
• 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

• Outer Diameter: 1.8 Millimeter
• Length: 400 Millimeter
• Outer Diameter: 1.8 Millimeter
• Length: 400 Millimeter
• Outer Diameter: 1.8 Millimeter
• Length: 400 Millimeter
• Outer Diameter: 1.8 Millimeter
• Length: 400 Millimeter
• Outer Diameter: 1.8 Millimeter
• Length: 400 Millimeter
• Outer Diameter: 1.8 Millimeter
• Length: 400 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889797102698 [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

[00889797102698]

Moist Heat or Steam Sterilization

[00889797102698]

Moist Heat or Steam Sterilization

[00889797102698]

Moist Heat or Steam Sterilization

[00889797102698]

Moist Heat or Steam Sterilization

[00889797102698]

Moist Heat or Steam Sterilization

[00889797102698]

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.

• 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
• 00889797107433 - Made-To-Order: 2024-09-11 Inbone® Strike Rod
• 00889797107457 - Made-To-Order: 2024-09-11 Inbone® Strike Rod
• 00889797107471 - Made-To-Order: 2024-09-11 Cartilage Removal Tool