U2 ACETABULAR COMPONENT

Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented

UNITED ORTHOPEDIC CORP.

The following data is part of a premarket notification filed by United Orthopedic Corp. with the FDA for U2 Acetabular Component.

Pre-market Notification Details

• Device ID: K050262
• 510k Number: K050262
• Device Name: U2 ACETABULAR COMPONENT
• Classification: Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented
• Applicant: UNITED ORTHOPEDIC CORP. 57 PARK AVE. 2, SCIENCE PARK Hsinchu, TW 300
• Contact: Gene Huang
• Correspondent: Gene Huang; UNITED ORTHOPEDIC CORP. 57 PARK AVE. 2, SCIENCE PARK Hsinchu, TW 300
• Product Code: LWJ
• CFR Regulation Number: 888.3360 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2005-02-04
• Decision Date: 2005-08-15
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04719872168379	K050262	000
04719872168331	K050262	000
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04712771509885	K050262	000