U-Motion II Set of Screw Hole Covers 1306-1001

GUDID 04712771497441

U-Motion II Set of Screw Hole Covers

UNITED ORTHOPEDIC CORP.

Ceramic-on-ceramic total hip prosthesis

• Primary Device ID: 04712771497441
• NIH Device Record Key: 07b5d473-a772-47d2-b524-38953334e5e3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: U-Motion II Set of Screw Hole Covers
• Version Model Number: 1306-1001
• Catalog Number: 1306-1001
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	04712771497441 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122185

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: 2018-08-07
• Device Publish Date: 2015-10-24

Devices Manufactured by UNITED ORTHOPEDIC CORP.

• 04719886901153 - United Hip System: 2025-01-30 Conformity Stem, Collared, #0
• 04719886901160 - United Hip System: 2025-01-30 Conformity Stem, Short Neck, Collared, #0
• 04719886901177 - United Hip System: 2025-01-30 Conformity Stem,#0
• 04719886901184 - United Hip System: 2025-01-30 Conformity Stem, Coxa Vara, 125° Std, Collared, #0
• 04719886904543 - U2 Total Knee System: 2025-01-22 Pin, Ø3.2mm×75mm
• 04719886904550 - U2 Total Knee System: 2025-01-22 Patellar drill guide, onset, NON-CEM, S, 29mm
• 04719886904567 - U2 Total Knee System: 2025-01-22 Patellar drill guide, onset, NON-CEM, M, 32mm
• 04719886904574 - U2 Total Knee System: 2025-01-22 Patellar drill guide, onset, NON-CEM, L, 35mm