X-PSI™ NEXGEN® 20-8085-002-01

GUDID 00889024486591

Orthosoft Inc

Orthopaedic prosthesis implantation instrument, single-use

• Primary Device ID: 00889024486591
• NIH Device Record Key: 3faa0960-e57d-4eba-8d9d-244985cba172
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: X-PSI™ NEXGEN®
• Version Model Number: 20-8085-002-01
• Catalog Number: 20-8085-002-01
• Company DUNS: 205670032
• Company Name: Orthosoft 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: 1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: 1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: 1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: 1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: 1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: 1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: 1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: 1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: 1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: 1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: 1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: 1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: 1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: 1(800)348-2759
• Email: zimmer.consumerrelations@zimmer.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889024486591 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171269

FDA Product Code

• JWH: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Sterilization

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

[00889024486591]

Moist Heat or Steam Sterilization

[00889024486591]

Moist Heat or Steam Sterilization

[00889024486591]

Moist Heat or Steam Sterilization

[00889024486591]

Moist Heat or Steam Sterilization

[00889024486591]

Moist Heat or Steam Sterilization

[00889024486591]

Moist Heat or Steam Sterilization

[00889024486591]

Moist Heat or Steam Sterilization

[00889024486591]

Moist Heat or Steam Sterilization

[00889024486591]

Moist Heat or Steam Sterilization

[00889024486591]

Moist Heat or Steam Sterilization

[00889024486591]

Moist Heat or Steam Sterilization

[00889024486591]

Moist Heat or Steam Sterilization

[00889024486591]

Moist Heat or Steam Sterilization

[00889024486591]

Moist Heat or Steam Sterilization

[00889024486591]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-02-07
• Device Publish Date: 2018-04-18

On-Brand Devices [X-PSI™ NEXGEN® ]

• 00889024486607: 20-8085-002-02
• 00889024486591: 20-8085-002-01