Trabecular Metal 20-8075-001-02

GUDID 00889024305809

Orthosoft Inc

Orthopaedic implant aiming arm

• Primary Device ID: 00889024305809
• NIH Device Record Key: 0df04fb1-089a-40db-a3b8-29eb427fc20d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Trabecular Metal
• Version Model Number: 20-8075-001-02
• Catalog Number: 20-8075-001-02
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889024305809 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131129

FDA Product Code

• KWS: Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented

Sterilization

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

[00889024305809]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-11-22
• Device Publish Date: 2016-09-07

On-Brand Devices [Trabecular Metal]

• 00889024305809: 20-8075-001-02
• 00889024305793: 20-8075-001-01
• 00889024304178: 20-8075-008-00
• 00889024304147: 20-8075-005-00
• 00889024304130: 20-8075-004-01
• 00889024304079: 20-8075-004-02