Trabecular Metal

GUDID 00889024304178

Orthosoft Inc

Orthopaedic prosthesis implantation instrument, single-use

• Primary Device ID: 00889024304178
• NIH Device Record Key: 2ae0e6be-3833-4e49-b947-55db1d50bda4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Trabecular Metal
• Version Model Number: 20-8075-008-00
• 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
• 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	00889024304178 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150730

FDA Product Code

• KWT: Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented

Sterilization

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

[00889024304178]

Moist Heat or Steam Sterilization

[00889024304178]

Moist Heat or Steam Sterilization

[00889024304178]

Moist Heat or Steam Sterilization

[00889024304178]

Moist Heat or Steam Sterilization

[00889024304178]

Moist Heat or Steam Sterilization

[00889024304178]

Moist Heat or Steam Sterilization

[00889024304178]

Moist Heat or Steam Sterilization

[00889024304178]

Moist Heat or Steam Sterilization

[00889024304178]

Moist Heat or Steam Sterilization

[00889024304178]

Moist Heat or Steam Sterilization

[00889024304178]

Moist Heat or Steam Sterilization

[00889024304178]

Moist Heat or Steam Sterilization

[00889024304178]

Moist Heat or Steam Sterilization

[00889024304178]

Moist Heat or Steam Sterilization

[00889024304178]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-02-07
• Device Publish Date: 2017-09-12

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