Locking cage, OD58mm, left 1308-1158

GUDID 04719872156109

Locking cage, OD58mm, left

UNITED ORTHOPEDIC CORP.

Acetabular shell

• Primary Device ID: 04719872156109
• NIH Device Record Key: 4cf4d17c-d3fb-4d5b-8950-110a2fa3cebf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Locking cage, OD58mm, left
• Version Model Number: 1308-1158
• Catalog Number: 1308-1158
• 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
• Phone: +886229294567
• Email: service@uoc.com.tw
• Phone: +886229294567
• Email: service@uoc.com.tw
• Phone: +886229294567
• Email: service@uoc.com.tw
• Phone: +886229294567
• Email: service@uoc.com.tw
• Phone: +886229294567
• Email: service@uoc.com.tw
• Phone: +886229294567
• Email: service@uoc.com.tw
• Phone: +886229294567
• Email: service@uoc.com.tw
• Phone: +886229294567
• Email: service@uoc.com.tw
• Phone: +886229294567
• Email: service@uoc.com.tw
• Phone: +886229294567
• Email: service@uoc.com.tw
• Phone: +886229294567
• Email: service@uoc.com.tw
• Phone: +886229294567
• Email: service@uoc.com.tw
• Phone: +886229294567
• Email: service@uoc.com.tw

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	04719872156109 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163441

FDA Product Code

• LZO: Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-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.

• 04719886904680 - U2 Total Knee System: 2025-02-25 Onset patellar peg drill, NON-CEM, Ø5.1mm
• 04719886904697 - U2 Total Knee System: 2025-02-25 Onset patellar peg drill, NON-CEM, Ø5.35mm
• 04719886904703 - U2 Total Knee System: 2025-02-25 Patellar capture, asymmetric onset, NON-CEM, S, Ø29mm
• 04719886904710 - U2 Total Knee System: 2025-02-25 Patellar capture, asymmetric onset, NON-CEM, M, Ø32mm
• 04719886904727 - U2 Total Knee System: 2025-02-25 Patellar capture, asymmetric onset, NON-CEM, L, Ø35mm
• 04719886904734 - U2 Total Knee System: 2025-02-25 Patellar capture, asymmetric onset, NON-CEM, XL, Ø38mm
• 04719886904741 - U2 Total Knee System: 2025-02-25 Patellar capture, asymmetric onset, NON-CEM, XXL, Ø41mm
• 04719886901153 - United Hip System: 2025-01-30 Conformity Stem, Collared, #0