Standard Tibial Insert 22-03-00-18-7

GUDID B0462203001870

Symmetric Total Knee Standard Tibial Insert Size 7x18

SIGNAL MEDICAL CORPORATION

Tibial insert

• Primary Device ID: B0462203001870
• NIH Device Record Key: 445de207-1181-41b1-b449-76375055f151
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Standard Tibial Insert
• Version Model Number: 7x18
• Catalog Number: 22-03-00-18-7
• 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: vfowler@signalmd.com
• Phone: 810-364-7070
• Email: vfowler@signalmd.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B0462203001870 [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: 2017-06-28

On-Brand Devices [Standard Tibial Insert]

• B0462203001850: Symmetric Total Knee Standard Tibial Insert Size 5x18
• B0462203001470: Symmetric Total Knee Standard Tibial Insert Size 7x14
• B0462203001450: Symmetric Total Knee Standard Tibial Insert Size 5x14
• B0462203001440: Symmetric Total Knee Standard Tibial Insert Size 4x14
• B0462203001270: Symmetric Total Knee Standard Tibial Insert Size 7x12
• B0462203001050: Symmetric Total Knee Standard Tibial Insert Size 5x10
• B0462203002070: Symmetric Total Knee Standard Tibial Insert Size 7x20
• B0462203002060: Symmetric Total Knee Standard Tibial Insert Size 6x20
• B0462203002050: Symmetric Total Knee Standard Tibial Insert Size 5x20
• B0462203002040: Symmetric Total Knee Standard Tibial Insert Size 4x20
• B0462203001870: Symmetric Total Knee Standard Tibial Insert Size 7x18
• B0462203001860: Symmetric Total Knee Standard Tibial Insert Size 6x18
• B0462203001840: Symmetric Total Knee Standard Tibial Insert Size 4x18
• B0462203001670: Symmetric Total Knee Standard Tibial Insert Size 7x16
• B0462203001660: Symmetric Total Knee Standard Tibial Insert Size 6x16
• B0462203001650: Symmetric Total Knee Standard Tibial Insert Size 5x16
• B0462203001640: Symmetric Total Knee Standard Tibial Insert Size 4x16
• B0462203001460: Symmetric Total Knee Standard Tibial Insert Size 6x14
• B0462203001260: Symmetric Total Knee Standard Tibial Insert Size 6x12
• B0462203001250: Symmetric Total Knee Standard Tibial Insert Size 5x12
• B0462203001240: Symmetric Total Knee Standard Tibial Insert Size 4x12
• B0462203001070: Symmetric Total Knee Standard Tibial Insert Size 7x10
• B0462203001060: Symmetric Total Knee Standard Tibial Insert Size 6x10
• B0462203001040: Symmetric Total Knee Standard Tibial Insert Size 4x10
• B0462203002030: Symmetric Total Knee Standard Tibial Insert Size 3x20
• B0462203001830: Symmetric Total Knee Standard Tibial Insert Size 3x18
• B0462203001630: Symmetric Total Knee Standard Tibial Insert Size 3x16
• B0462203001430: Symmetric Total Knee Standard Tibial Insert Size 3x14
• B0462203001230: Symmetric Total Knee Standard Tibial Insert Size 3x12
• B0462203001030: Symmetric Total Knee Standard Tibial Insert Size 3x10