Ultra Tibial Insert 22-03-01-35-3

GUDID B0462203013530

Symmetric Total Knee Ultra Tibial Insert Size 3x35

SIGNAL MEDICAL CORPORATION

Tibial insert

• Primary Device ID: B0462203013530
• NIH Device Record Key: 47c682e9-1637-4ce3-b2d9-5ec79d9a9ea8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ultra Tibial Insert
• Version Model Number: 3x35
• Catalog Number: 22-03-01-35-3
• 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	B0462203013530 [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 [Ultra Tibial Insert]

• B0462203013570: Symmetric Total Knee Ultra Tibial Insert Size 7x35
• B0462203013560: Symmetric Total Knee Ultra Tibial Insert Size 6x35
• B0462203013550: Symmetric Total Knee Ultra Tibial Insert Size 5x35
• B0462203013540: Symmetric Total Knee Ultra Tibial Insert Size 4x35
• B0462203013070: Symmetric Total Knee Ultra Tibial Insert Size 7x30
• B0462203013060: Symmetric Total Knee Ultra Tibial Insert Size 6x30
• B0462203013050: Symmetric Total Knee Ultra Tibial Insert Size 5x30
• B0462203013040: Symmetric Total Knee Ultra Tibial Insert Size 4x30
• B0462203012570: Symmetric Total Knee Ultra Tibial Insert Size 7x25
• B0462203012560: Symmetric Total Knee Ultra Tibial Insert Size 6x25
• B0462203012550: Symmetric Total Knee Ultra Tibial Insert Size 5x25
• B0462203012540: Symmetric Total Knee Ultra Tibial Insert Size 4x25
• B0462203012070: Symmetric Total Knee Ultra Tibial Insert Size 7x20
• B0462203012060: Symmetric Total Knee Ultra Tibial Insert Size 6x20
• B0462203012050: Symmetric Total Knee Ultra Tibial Insert Size 5x20
• B0462203012040: Symmetric Total Knee Ultra Tibial Insert Size 4x20
• B0462203011870: Symmetric Total Knee Ultra Tibial Insert Size 7x18
• B0462203011860: Symmetric Total Knee Ultra Tibial Insert Size 6x18
• B0462203011850: Symmetric Total Knee Ultra Tibial Insert Size 5x18
• B0462203011840: Symmetric Total Knee Ultra Tibial Insert Size 4x18
• B0462203011670: Symmetric Total Knee Ultra Tibial Insert Size 7x16
• B0462203011660: Symmetric Total Knee Ultra Tibial Insert Size 6x16
• B0462203011650: Symmetric Total Knee Ultra Tibial Insert Size 5x16
• B0462203011640: Symmetric Total Knee Ultra Tibial Insert Size 4x16
• B0462203011470: Symmetric Total Knee Ultra Tibial Insert Size 7x14
• B0462203011460: Symmetric Total Knee Ultra Tibial Insert Size 6x14
• B0462203011450: Symmetric Total Knee Ultra Tibial Insert Size 5x14
• B0462203011440: Symmetric Total Knee Ultra Tibial Insert Size 4x14
• B0462203011270: Symmetric Total Knee Ultra Tibial Insert Size 7x12
• B0462203011260: Symmetric Total Knee Ultra Tibial Insert Size 6x12
• B0462203011250: Symmetric Total Knee Ultra Tibial Insert Size 5x12
• B0462203011240: Symmetric Total Knee Ultra Tibial Insert Size 4x12
• B0462203011070: Symmetric Total Knee Ultra Tibial Insert Size 7x10
• B0462203011060: Symmetric Total Knee Ultra Tibial Insert Size 6x10
• B0462203011050: Symmetric Total Knee Ultra Tibial Insert Size 5x10
• B0462203011040: Symmetric Total Knee Ultra Tibial Insert Size 4x10
• B0462203013530: Symmetric Total Knee Ultra Tibial Insert Size 3x35
• B0462203013030: Symmetric Total Knee Ultra Tibial Insert Size 3x30
• B0462203012030: Symmetric Total Knee Ultra Tibial Insert Size 3x20
• B0462203011830: Symmetric Total Knee Ultra Tibial Insert Size 3x18
• B0462203011630: Symmetric Total Knee Ultra Tibial Insert Size 3x16
• B0462203011430: Symmetric Total Knee Ultra Tibial Insert Size 3x14
• B0462203011230: Symmetric Total Knee Ultra Tibial Insert Size 3x12
• B0462203011030: Symmetric Total Knee Ultra Tibial Insert Size 3x10