Symmetric TK Femoral Component 22-01-02103

GUDID B0462201021030

3RT Symmetric TK Femoral Component

SIGNAL MEDICAL CORPORATION

Coated knee femur prosthesis

• Primary Device ID: B0462201021030
• NIH Device Record Key: da7a77de-4bb9-4b54-a626-3961e607d4a4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Symmetric TK Femoral Component
• Version Model Number: 3RT
• Catalog Number: 22-01-02103
• 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: 8103647070
• Email: vfowler@signalmd.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B0462201021030 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-12-12
• Device Publish Date: 2019-12-04

On-Brand Devices [Symmetric TK Femoral Component]

• B046220102104: 4RT Symmetric TK Femoral Component
• B0462201021050: 5RT Symmetric TK Femoral Component
• B0462201020070: 7LT Symmetric TK Femoral Component
• B0462201020060: Symmetric TK Femoral Component 6LT
• B0462201020050: 5LT Symmetric TK Femoral Component
• B0462201020040: 4LT Symmetric TK Femoral Component
• B0462201021030: 3RT Symmetric TK Femoral Component
• B0462201020030: 3LT Symmetric TK Femoral Component