U2 Femoral head, 3/4 polished, Ø36mm, +2.5mm 1206-3236

GUDID 04719872155324

U2 Femoral head, 3/4 polished, Ø36mm, +2.5mm

UNITED ORTHOPEDIC CORP.

Metal-on-polyethylene total hip prosthesis

• Primary Device ID: 04719872155324
• NIH Device Record Key: a2f4f3ad-82ea-4d50-8d6f-3cec3146bcce
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: U2 Femoral head, 3/4 polished, Ø36mm, +2.5mm
• Version Model Number: 1206-3236
• Catalog Number: 1206-3236
• 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	04719872155324 [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.

• 04719886902839 - Resolve Modular Revision Hip Stem: 2025-05-22 Resolve taper stem trial, Ø16×140mm
• 04719886902846 - Resolve Modular Revision Hip Stem: 2025-05-22 Resolve taper stem trial, Ø17×140mm
• 04719886902853 - Resolve Modular Revision Hip Stem: 2025-05-22 Resolve taper stem trial, Ø18×140mm
• 04719886902860 - Resolve Modular Revision Hip Stem: 2025-05-22 Resolve taper stem trial, Ø19×140mm
• 04719886902877 - Resolve Modular Revision Hip Stem: 2025-05-22 Resolve taper stem trial, Ø20×140mm
• 04719886902884 - Resolve Modular Revision Hip Stem: 2025-05-22 Resolve taper stem trial, Ø21×140mm
• 04719886902891 - Resolve Modular Revision Hip Stem: 2025-05-22 Resolve taper stem trial, Ø22×140mm
• 04719886902907 - Resolve Modular Revision Hip Stem: 2025-05-22 Resolve taper stem trial, Ø23×140mm