U2 ACETABULAR CUP, PLASMA SPRAY

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 U2 Acetabular Cup, Plasma Spray.

Pre-market Notification Details

• Device ID: K121777
• 510k Number: K121777
• Device Name: U2 ACETABULAR CUP, PLASMA SPRAY
• Classification: Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
• Applicant: UNITED ORTHOPEDIC CORP. 57 PARK AVE. 2, SCIENCE PARK Hsinchu, TW 300
• Contact: Fang-yuan Ho
• Correspondent: Fang-yuan Ho; 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: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-06-18
• Decision Date: 2012-07-18
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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