U2 Femoral head, Ø28mm, -3mm 1206-1028

GUDID 04719872154914

U2 Femoral head, Ø28mm, -3mm

UNITED ORTHOPEDIC CORP.

Metal-on-polyethylene total hip prosthesis

• Primary Device ID: 04719872154914
• NIH Device Record Key: 0d5113ba-962b-4328-8374-d30b54135e0a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: U2 Femoral head, Ø28mm, -3mm
• Version Model Number: 1206-1028
• Catalog Number: 1206-1028
• 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	04719872154914 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162957

FDA Product Code

• LPH: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

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: 2018-08-08
• Device Publish Date: 2017-10-06

Devices Manufactured by UNITED ORTHOPEDIC CORP.

• 04719886903546 - Resolve Modular Revision Stem: 2024-10-08 Proximal screw extractor, HEX 5
• 04719886903645 - U2 Total Knee System: 2024-10-08 Tibial cutting jig, open slot, 0°, left
• 04719886903652 - U2 Total Knee System: 2024-10-08 Tibial cutting jig, open slot, 0°, right
• 04719886903515 - Conformity Stem: 2024-10-04 Broach, #0
• 04719886903522 - Conformity Stem: 2024-10-04 Sharp broach, #0
• 04719886903539 - Conformity Stem: 2024-10-04 Sharp broach, #0
• 04719872145486 - United Hip System: 2024-09-20 Conformity stem, short neck, collared, #4
• 04719872145493 - United Hip System: 2024-09-20 Conformity stem, short neck, collared, #5