Symmetric Total Knee Femoral Component 22-01-02106

GUDID B0462201021060

Size: 6RT Symmetric Total Knee Femoral Component

SIGNAL MEDICAL CORPORATION

Coated knee femur prosthesis

• Primary Device ID: B0462201021060
• NIH Device Record Key: 46b7bf0c-dbe3-4392-9723-fa04e6f77c8b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Symmetric Total Knee Femoral Component
• Version Model Number: 6RT
• Catalog Number: 22-01-02106
• Company DUNS: 169289308
• Company Name: SIGNAL MEDICAL CORPORATION
• 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: true
• Manufacturing Date: true
• Expiration Date: true
• 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: 1-810-364-7070
• Email: jgorney@signalmd.com
• Phone: 1-810-364-7070
• Email: jgorney@signalmd.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B0462201021060 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080199

FDA Product Code

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

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-01-06

On-Brand Devices [Symmetric Total Knee Femoral Component]

• B0462201021070: Size: 7RT Symmetric Total Knee Femoral Component
• B0462201021060: Size: 6RT Symmetric Total Knee Femoral Component