UTF STEM, REDUCED

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

UNITED ORTHOPEDIC CORPORATION

The following data is part of a premarket notification filed by United Orthopedic Corporation with the FDA for Utf Stem, Reduced.

Pre-market Notification Details

• Device ID: K123550
• 510k Number: K123550
• Device Name: UTF STEM, REDUCED
• Classification: Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
• Applicant: UNITED ORTHOPEDIC CORPORATION NO 57, PARK AVE 2, SCIENCE PARK Hsinchu, TW 300
• Contact: Fang-yuan Ho
• Correspondent: Fang-yuan Ho; UNITED ORTHOPEDIC CORPORATION NO 57, PARK AVE 2, SCIENCE PARK Hsinchu, TW 300
• Product Code: LPH
• Subsequent Product Code: KWY
• Subsequent Product Code: LZO
• CFR Regulation Number: 888.3358 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-11-19
• Decision Date: 2013-05-01
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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