Metaphyseal Stem 22-05-102465

GUDID B04622051024650

24 x 65 Metaphyseal Stem

SIGNAL MEDICAL CORPORATION

Knee femur stem prosthesis

• Primary Device ID: B04622051024650
• NIH Device Record Key: 27a5bb84-bfba-41b0-bc3b-dfeb3d61a63c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Metaphyseal Stem
• Version Model Number: 24 x 65
• Catalog Number: 22-05-102465
• 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: 810-364-7070
• Email: jgorney@signalmd.com
• Phone: 810-364-7070
• Email: jgorney@signalmd.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B04622051024650 [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: 4
• Public Version Date: 2020-04-20
• Device Publish Date: 2016-06-09

On-Brand Devices [Metaphyseal Stem]

• B04622051024650: 24 x 65 Metaphyseal Stem
• B04622051022600: 22 x 60 Metaphyseal Stem
• B04622051020550: 20 x 55 Metaphyseal Stem