Cellbrick Knee Spacer 9909-8310

GUDID 04719886900958

Cellbrick Knee Spacer instrument, tray #1

UNITED ORTHOPEDIC CORP.

Instrument tray, reusable

• Primary Device ID: 04719886900958
• NIH Device Record Key: e86dc204-e12c-45af-9f04-8bb2c9a324f0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cellbrick Knee Spacer
• Version Model Number: 9909-8310
• Catalog Number: 9909-8310
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• 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: tw.service@unitedorthopedic.com
• Phone: +886229294567
• Email: tw.service@unitedorthopedic.com
• Phone: +886229294567
• Email: tw.service@unitedorthopedic.com
• Phone: +886229294567
• Email: tw.service@unitedorthopedic.com
• Phone: +886229294567
• Email: tw.service@unitedorthopedic.com
• Phone: +886229294567
• Email: tw.service@unitedorthopedic.com
• Phone: +886229294567
• Email: tw.service@unitedorthopedic.com
• Phone: +886229294567
• Email: tw.service@unitedorthopedic.com
• Phone: +886229294567
• Email: tw.service@unitedorthopedic.com
• Phone: +886229294567
• Email: tw.service@unitedorthopedic.com
• Phone: +886229294567
• Email: tw.service@unitedorthopedic.com
• Phone: +886229294567
• Email: tw.service@unitedorthopedic.com
• Phone: +886229294567
• Email: tw.service@unitedorthopedic.com
• Phone: +886229294567
• Email: tw.service@unitedorthopedic.com
• Phone: +886229294567
• Email: tw.service@unitedorthopedic.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04719886900958 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243024

FDA Product Code

• JWH: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[04719886900958]

Moist Heat or Steam Sterilization

[04719886900958]

Moist Heat or Steam Sterilization

[04719886900958]

Moist Heat or Steam Sterilization

[04719886900958]

Moist Heat or Steam Sterilization

[04719886900958]

Moist Heat or Steam Sterilization

[04719886900958]

Moist Heat or Steam Sterilization

[04719886900958]

Moist Heat or Steam Sterilization

[04719886900958]

Moist Heat or Steam Sterilization

[04719886900958]

Moist Heat or Steam Sterilization

[04719886900958]

Moist Heat or Steam Sterilization

[04719886900958]

Moist Heat or Steam Sterilization

[04719886900958]

Moist Heat or Steam Sterilization

[04719886900958]

Moist Heat or Steam Sterilization

[04719886900958]

Moist Heat or Steam Sterilization

[04719886900958]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-03-27
• Device Publish Date: 2025-03-19

On-Brand Devices [Cellbrick Knee Spacer]

• 04719886901757: Femoal spacer sizing template, #4~#5
• 04719886901740: Femoal spacer sizing template, #2~#3
• 04719886901641: Canal rod extractor
• 04719886906219: Tibial spacer mold, #5
• 04719886906202: Tibial spacer mold, #4
• 04719886906196: Tibial spacer mold, #3
• 04719886906189: Tibial spacer mold, #2
• 04719886906172: Femoral spacer mold, #5
• 04719886906165: Femoral spacer mold, #4
• 04719886906158: Femoral spacer mold, #3
• 04719886906141: Femoral spacer mold, #2
• 04719886900965: Cellbrick Knee Spacer instrument, tray #2
• 04719886900958: Cellbrick Knee Spacer instrument, tray #1
• 04719886900941: Tibial spacer mold case
• 04719886900934: Femoral spacer mold case
• 04719872142782: Cellbrick Knee Spacer Canal Rod, 4mm Dia., 80mm Length
• 04719872142775: Cellbrick Knee Spacer Tibial Spacer, #5, 10mm Thick
• 04719872142768: Cellbrick Knee Spacer Tibial Spacer, #4, 10mm Thick
• 04719872142751: Cellbrick Knee Spacer Tibial Spacer, #3, 10mm Thick
• 04719872142744: Cellbrick Knee Spacer Tibial Spacer, #2, 10mm Thick
• 04719872142737: Cellbrick Knee Spacer Tibial Spacer, #1, 10mm Thick
• 04719872142720: Cellbrick Knee Spacer Femoral Spacer, #5
• 04719872142713: Cellbrick Knee Spacer Femoral Spacer, #4
• 04719872142706: Cellbrick Knee Spacer Femoral Spacer, #3
• 04719872142690: Cellbrick Knee Spacer Femoral Spacer, #2
• 04719872142683: Cellbrick Knee Spacer Femoral Spacer, #1