U2 HIP STEM, TI PLASMA SPRAY

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 Hip Stem, Ti Plasma Spray.

Pre-market Notification Details

• Device ID: K062978
• 510k Number: K062978
• Device Name: U2 HIP STEM, TI PLASMA SPRAY
• 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: 2006-09-29
• Decision Date: 2007-01-16
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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