U1 HIP SYSTEM

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

UNITED ORTHOPEDIC CORP.

The following data is part of a premarket notification filed by United Orthopedic Corp. with the FDA for U1 Hip System.

Pre-market Notification Details

• Device ID: K994078
• 510k Number: K994078
• Device Name: U1 HIP SYSTEM
• Classification: Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
• Applicant: UNITED ORTHOPEDIC CORP. 57 PARK AVE. 2, SCIENCE PARK Hsinchu, TW 300
• Contact: Mellen Liu
• Correspondent: Mellen Liu; UNITED ORTHOPEDIC CORP. 57 PARK AVE. 2, SCIENCE PARK Hsinchu, TW 300
• Product Code: LPH
• CFR Regulation Number: 888.3358 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1999-12-02
• Decision Date: 2000-12-04
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04719872159285	K994078	000
04712602340083	K994078	000
04712602340137	K994078	000
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