U2 Hip Stem, Revision Hip Stem With Collar, Straig 1104-1214

GUDID 04712602340397

Revision hip stem, Ti plasma spray, With collar, Straight, Ø14x180mm

UNITED ORTHOPEDIC CORP.

Metal-on-polyethylene total hip prosthesis

• Primary Device ID: 04712602340397
• NIH Device Record Key: e78a381b-8dd1-4736-bb61-3bd6e2dd3fb0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: U2 Hip Stem, Revision Hip Stem With Collar, Straig
• Version Model Number: 1104-1214
• Catalog Number: 1104-1214
• 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	04712602340397 [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: 2018-08-02
• Device Publish Date: 2015-10-24

On-Brand Devices [U2 Hip Stem, Revision Hip Stem With Collar, Straig]

• 04712602340427: Revision hip stem, Ti plasma spray, With collar, Straight, Ø18x180mm
• 04712602340410: Revision hip stem, Ti plasma spray, With collar, Straight, Ø16.5x180mm
• 04712602340403: Revision hip stem, Ti plasma spray, With collar, Straight, Ø15x180mm
• 04712602340397: Revision hip stem, Ti plasma spray, With collar, Straight, Ø14x180mm
• 04712602340380: Revision hip stem, Ti plasma spray, With collar, Straight, Ø13x180mm
• 04712602340373: Revision hip stem, Ti plasma spray, With collar, Straight, Ø12x180mm
• 04712602340366: Revision hip stem, Ti plasma spray, With collar, Straight, Ø11x180mm