U2 Hip Stem, Revision Hip Stem Collarless, Curved 1104-1816

GUDID 04712602340762

Revision hip stem, Ti plasma spray, Collarless, Curved, Right, Ø16.5x230mm

UNITED ORTHOPEDIC CORP.

Metal-on-polyethylene total hip prosthesis

• Primary Device ID: 04712602340762
• NIH Device Record Key: 551f5f5c-d604-438b-9385-b0cdfae56dc5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: U2 Hip Stem, Revision Hip Stem Collarless, Curved
• Version Model Number: 1104-1816
• Catalog Number: 1104-1816
• 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	04712602340762 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062978

FDA Product Code

• LWJ: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, 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: 2018-08-03
• Device Publish Date: 2015-10-24

On-Brand Devices [U2 Hip Stem, Revision Hip Stem Collarless, Curved]

• 04712602340779: Revision hip stem, Ti plasma spray, Collarless, Curved, Right, Ø18x230mm
• 04712602340762: Revision hip stem, Ti plasma spray, Collarless, Curved, Right, Ø16.5x230mm
• 04712602340755: Revision hip stem, Ti plasma spray, Collarless, Curved, Right, Ø15x230mm
• 04712602340748: Revision hip stem, Ti plasma spray, Collarless, Curved, Right, Ø14x230mm
• 04712602340731: Revision hip stem, Ti plasma spray, Collarless, Curved, Right, Ø13x230mm
• 04712602340724: Revision hip stem, Ti plasma spray, Collarless, Curved, Right, Ø12x230mm
• 04712602340717: Revision hip stem, Ti plasma spray, Collarless, Curved, Right, Ø11x230mm
• 04712602340700: Revision hip stem, Ti plasma spray, Collarless, Curved, Left, Ø18x230mm
• 04712602340694: Revision hip stem, Ti plasma spray, Collarless, Curved, Left, Ø16.5x230mm
• 04712602340687: Revision hip stem, Ti plasma spray, Collarless, Curved, Left, Ø15x230mm
• 04712602340670: Revision hip stem, Ti plasma spray, Collarless, Curved, Left, Ø14x230mm
• 04712602340663: Revision hip stem, Ti plasma spray, Collarless, Curved, Left, Ø13x230mm
• 04712602340656: Revision hip stem, Ti plasma spray, Collarless, Curved, Left, Ø12x230mm
• 04712602340649: Revision hip stem, Ti plasma spray, Collarless, Curved, Left, Ø11x230mm