Fusion Cups FC04

GUDID 00842188100703

Fusion Half Cup, 4 Hole, 18mm

TRIMED, INCORPORATED

Orthopaedic fixation plate, non-bioabsorbable, non-sterile

• Primary Device ID: 00842188100703
• NIH Device Record Key: 4dd3daed-6789-4a73-b590-6e239084e250
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fusion Cups
• Version Model Number: FC04
• Catalog Number: FC04
• Company DUNS: 138041277
• Company Name: TRIMED, INCORPORATED
• 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(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842188100703 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K050681

FDA Product Code

• HRS: Plate, fixation, bone

Sterilization

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

[00842188100703]

Moist Heat or Steam Sterilization

[00842188100703]

Moist Heat or Steam Sterilization

[00842188100703]

Moist Heat or Steam Sterilization

[00842188100703]

Moist Heat or Steam Sterilization

[00842188100703]

Moist Heat or Steam Sterilization

[00842188100703]

Moist Heat or Steam Sterilization

[00842188100703]

Moist Heat or Steam Sterilization

[00842188100703]

Moist Heat or Steam Sterilization

[00842188100703]

Moist Heat or Steam Sterilization

[00842188100703]

Moist Heat or Steam Sterilization

[00842188100703]

Moist Heat or Steam Sterilization

[00842188100703]

Moist Heat or Steam Sterilization

[00842188100703]

Moist Heat or Steam Sterilization

[00842188100703]

Moist Heat or Steam Sterilization

[00842188100703]

Moist Heat or Steam Sterilization

[00842188100703]

Moist Heat or Steam Sterilization

[00842188100703]

Moist Heat or Steam Sterilization

[00842188100703]

Moist Heat or Steam Sterilization

[00842188100703]

Moist Heat or Steam Sterilization

[00842188100703]

Moist Heat or Steam Sterilization

[00842188100703]

Moist Heat or Steam Sterilization

[00842188100703]

Moist Heat or Steam Sterilization

[00842188100703]

Moist Heat or Steam Sterilization

[00842188100703]

Moist Heat or Steam Sterilization

[00842188100703]

Moist Heat or Steam Sterilization

[00842188100703]

Moist Heat or Steam Sterilization

[00842188100703]

Moist Heat or Steam Sterilization

[00842188100703]

Moist Heat or Steam Sterilization

[00842188100703]

Moist Heat or Steam Sterilization

[00842188100703]

Moist Heat or Steam Sterilization

[00842188100703]

Moist Heat or Steam Sterilization

[00842188100703]

Moist Heat or Steam Sterilization

[00842188100703]

Moist Heat or Steam Sterilization

[00842188100703]

Moist Heat or Steam Sterilization

[00842188100703]

Moist Heat or Steam Sterilization

[00842188100703]

Moist Heat or Steam Sterilization

[00842188100703]

Moist Heat or Steam Sterilization

[00842188100703]

Moist Heat or Steam Sterilization

[00842188100703]

Moist Heat or Steam Sterilization

[00842188100703]

Moist Heat or Steam Sterilization

[00842188100703]

Moist Heat or Steam Sterilization

[00842188100703]

Moist Heat or Steam Sterilization

[00842188100703]

Moist Heat or Steam Sterilization

[00842188100703]

Moist Heat or Steam Sterilization

[00842188100703]

Moist Heat or Steam Sterilization

[00842188100703]

Moist Heat or Steam Sterilization

[00842188100703]

Moist Heat or Steam Sterilization

[00842188100703]

Moist Heat or Steam Sterilization

[00842188100703]

Moist Heat or Steam Sterilization

[00842188100703]

Moist Heat or Steam Sterilization

[00842188100703]

Moist Heat or Steam Sterilization

[00842188100703]

Moist Heat or Steam Sterilization

[00842188100703]

Moist Heat or Steam Sterilization

[00842188100703]

Moist Heat or Steam Sterilization

[00842188100703]

Moist Heat or Steam Sterilization

[00842188100703]

Moist Heat or Steam Sterilization

[00842188100703]

Moist Heat or Steam Sterilization

[00842188100703]

Moist Heat or Steam Sterilization

[00842188100703]

Moist Heat or Steam Sterilization

[00842188100703]

Moist Heat or Steam Sterilization

[00842188100703]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-07

On-Brand Devices [Fusion Cups]

• 00842188101359: Sub-Talar Fusion Cup Small
• 00842188100741: Fusion Cup, 10 Hole, 22mm
• 00842188100734: Fusion Cup, 10 Hole, 18mm
• 00842188100727: Fusion Cup, 7 Hole, 14mm
• 00842188100710: Fusion Half Cup, 6 Hole, 22mm
• 00842188100703: Fusion Half Cup, 4 Hole, 18mm