Tibial augment 2803-5052

GUDID 04712602349697

Tibial augment, #5, 10mm

UNITED ORTHOPEDIC CORP.

Posterior-stabilized total knee prosthesis

• Primary Device ID: 04712602349697
• NIH Device Record Key: 91453332-d204-4808-abd7-a4b745db46f7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tibial augment
• Version Model Number: 2803-5052
• Catalog Number: 2803-5052
• Company DUNS: 656700556
• Company Name: UNITED ORTHOPEDIC CORP.
• 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: false
• Manufacturing Date: false
• 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: +886229294567
• Email: service@uoc.com.tw

Device Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	04712602349697 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082424

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: 2018-07-18
• Device Publish Date: 2015-10-24

On-Brand Devices [Tibial augment]

• 04712771482720: Tibial augment, #6, 30mm
• 04712771482713: Tibial augment, #5, 30mm
• 04712771482706: Tibial augment, #4, 30mm
• 04712771482690: Tibial augment, #3, 30mm
• 04712771482683: Tibial augment, #2, 30mm
• 04712771482676: Tibial augment, #1, 30mm
• 04712771482669: Tibial augment, #6, 15mm
• 04712771482652: Tibial augment, #5, 15mm
• 04712771482645: Tibial augment, #4, 15mm
• 04712771482638: Tibial augment, #3, 15mm
• 04712771482621: Tibial augment, #2, 15mm
• 04712771482614: Tibial augment, #1, 15mm
• 04712771480351: Tibial augment, #6, 10mm
• 04712771480344: Tibial augment, #6, 5mm
• 04712602349697: Tibial augment, #5, 10mm
• 04712602349680: Tibial augment, #5, 5mm
• 04712602349673: Tibial augment, #4, 10mm
• 04712602349666: Tibial augment, #4, 5mm
• 04712602349659: Tibial augment, #3, 10mm
• 04712602349642: Tibial augment, #3, 5mm
• 04712602349635: Tibial augment, #2, 10mm
• 04712602349628: Tibial augment, #2, 5mm
• 04712602349611: Tibial augment, #1, 10mm
• 04712602349604: Tibial augment, #1, 5mm