Coated Revision Stem 22-08-1112100

GUDID B046220811121000

12x100 Coated Revision Stem

SIGNAL MEDICAL CORPORATION

Sleeve femoral/tibial extension, coated Sleeve femoral/tibial extension, coated Sleeve femoral/tibial extension, coated Sleeve femoral/tibial extension, coated Sleeve femoral/tibial extension, coated Sleeve femoral/tibial extension, coated Sleeve femoral/tibial extension, coated Sleeve femoral/tibial extension, coated Sleeve femoral/tibial extension, coated Sleeve femoral/tibial extension, coated Sleeve femoral/tibial extension, coated Sleeve femoral/tibial extension, coated Sleeve femoral/tibial extension, coated Sleeve femoral/tibial extension, coated Sleeve femoral/tibial extension, coated

• Primary Device ID: B046220811121000
• NIH Device Record Key: 65907a73-ea79-4ee3-8cda-f2eda9f5788c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Coated Revision Stem
• Version Model Number: 12x100
• Catalog Number: 22-08-1112100
• 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
• Phone: 8103647070
• Email: vfowler@signalmd.com
• Phone: 8103647070
• Email: vfowler@signalmd.com
• Phone: 8103647070
• Email: vfowler@signalmd.com
• Phone: 8103647070
• Email: vfowler@signalmd.com
• Phone: 8103647070
• Email: vfowler@signalmd.com
• Phone: 8103647070
• Email: vfowler@signalmd.com
• Phone: 8103647070
• Email: vfowler@signalmd.com
• Phone: 8103647070
• Email: vfowler@signalmd.com
• Phone: 8103647070
• Email: vfowler@signalmd.com
• Phone: 8103647070
• Email: vfowler@signalmd.com
• Phone: 8103647070
• Email: vfowler@signalmd.com
• Phone: 8103647070
• Email: vfowler@signalmd.com
• Phone: 8103647070
• Email: vfowler@signalmd.com
• Phone: 8103647070
• Email: vfowler@signalmd.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B046220811121000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100370

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: 2021-02-03
• Device Publish Date: 2021-01-26

On-Brand Devices [Coated Revision Stem]

• B046220811241500: 24x150 Coated Revision Stem
• B046220811222000: 22x200 Coated Revision Stem
• B046220811221500: 22x150 Coated Revision Stem
• B046220811202000: 20x200 Coated Revision Stem
• B046220811201000: 20x100 Coated Revision Stem
• B046220811182000: 18x200 Coated Revision Stem
• B046220811181000: 18x100 Coated Revision Stem
• B046220811162000: 16x200 Coated Revision Stem
• B046220811161500: 16x150 Coated Revision Stem
• B046220811161000: 16x100 Coated Revision Stem
• B046220811142000: 14x200 Coated Revision Stem
• B046220811141500: 14x150 Coated Revision Stem
• B046220811141000: 14x100 Coated Revision Stem
• B046220811201500: 20x150 Coated Revision Stem
• B046220811181500: 18x150 Coated Revision Stem
• B046220811121500: 12x150 Coated Revision Stem
• B046220811261500: 26x150 Coated Revision Stem
• B046220811121000: 12x100 Coated Revision Stem
• B046220811122000: 12x200 Coated Revision Stem
• B046220811102000: 10x200 Coated Revision Stem
• B046220811101000: 10x100 Coated Revision Stem
• B046220811262000: 26x200 Coated Revision Stem
• B046220811261000: 26x100 Coated Revision Stem
• B046220811242000: 24x200 Coated Revision Stem
• B046220811241000: 24x100 Coated Revision Stem
• B046220811221000: 22x100 Coated Revision Stem
• B046220811101500: 10x150 Coated Revision Stem