U1 Hip System, Cancellous Bone Screw 5200-6515

GUDID 04712602344623

Co-Cr cancellous bone screw,15mm

UNITED ORTHOPEDIC CORP.

Metal-on-polyethylene total hip prosthesis

• Primary Device ID: 04712602344623
• NIH Device Record Key: 5e29ac75-092e-441d-a7bf-fa275e4086df
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: U1 Hip System, Cancellous Bone Screw
• Version Model Number: 5200-6515
• Catalog Number: 5200-6515
• 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

• Length: 15 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	04712602344623 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K994078

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: 2018-08-02
• Device Publish Date: 2015-10-24

On-Brand Devices [U1 Hip System, Cancellous Bone Screw]

• 04712602344678: Co-Cr cancellous bone screw,40mm
• 04712602344661: Co-Cr cancellous bone screw,35mm
• 04712602344654: Co-Cr cancellous bone screw,30mm
• 04712602344647: Co-Cr cancellous bone screw,25mm
• 04712602344630: Co-Cr cancellous bone screw,20mm
• 04712602344623: Co-Cr cancellous bone screw,15mm