Resolve Modular Revision Hip Stem 1112-1221

GUDID 04719886894851

Resolve Proximal Component, Ø21×65mm

UNITED ORTHOPEDIC CORP.

Coated hip femur prosthesis, modular

• Primary Device ID: 04719886894851
• NIH Device Record Key: dd1a671c-57b3-477e-8ada-636d28624161
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Resolve Modular Revision Hip Stem
• Version Model Number: 1112-1221
• Catalog Number: 1112-1221
• 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: tw.service@unitedorthopedic.com
• Phone: +886229294567
• Email: tw.service@unitedorthopedic.com
• Phone: +886229294567
• Email: tw.service@unitedorthopedic.com
• Phone: +886229294567
• Email: tw.service@unitedorthopedic.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04719886894851 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K242315

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-05-19
• Device Publish Date: 2025-05-09

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• 04719886894929: Resolve Proximal Component, Ø19×85mm
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• 04719886894905: Resolve Proximal Component, Ø23×75mm
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• 04719886894875: Resolve Proximal Component, Ø25×65mm
• 04719886894868: Resolve Proximal Component, Ø23×65mm
• 04719886894851: Resolve Proximal Component, Ø21×65mm
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