CERAMIC FEMORAL HEAD

Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate

UNITED ORTHOPEDIC CORP.

The following data is part of a premarket notification filed by United Orthopedic Corp. with the FDA for Ceramic Femoral Head.

Pre-market Notification Details

• Device ID: K103497
• 510k Number: K103497
• Device Name: CERAMIC FEMORAL HEAD
• Classification: Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate
• 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: MEH
• Subsequent Product Code: LPH
• Subsequent Product Code: LWJ
• CFR Regulation Number: 888.3353 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2010-11-29
• Decision Date: 2011-03-04

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04719872178989	K103497	000
04712771494907	K103497	000
04712771494914	K103497	000
04712771494921	K103497	000
04712771494938	K103497	000
04712771494945	K103497	000
04712771494952	K103497	000
04712771494969	K103497	000
04719872159810	K103497	000
04719872159827	K103497	000
04719872159834	K103497	000
04719872159841	K103497	000
04719872159858	K103497	000
04719872159865	K103497	000
04719872159872	K103497	000
04719872159889	K103497	000
04712602341653	K103497	000
04712602341646	K103497	000
04712602341622	K103497	000
04719872178996	K103497	000
04719872179009	K103497	000
04719872179016	K103497	000
04719872179023	K103497	000
04719872179030	K103497	000
04711605586665	K103497	000
04711605586696	K103497	000
04711605586702	K103497	000
04711605586733	K103497	000
04711605586740	K103497	000
04711605586771	K103497	000
04711605586658	K103497	000
04712602341585	K103497	000
04712602341592	K103497	000
04712602341615	K103497	000
04719872159896	K103497	000
04719872159902	K103497	000
04719872159919	K103497	000
04719872160120	K103497	000
04719872167792	K103497	000
04719872167808	K103497	000
04719872167822	K103497	000
04719872167839	K103497	000
04719872167853	K103497	000
04719872167860	K103497	000
04719872168454	K103497	000
04719872168461	K103497	000
04719872168478	K103497	000
04719872168485	K103497	000
04719872168492	K103497	000
04719872168508	K103497	000
04719872168515	K103497	000
04719872168522	K103497	000
04719872160113	K103497	000
04719872160106	K103497	000
04719872160090	K103497	000
04719872159926	K103497	000
04719872159933	K103497	000
04719872159940	K103497	000
04719872159957	K103497	000
04719872159964	K103497	000
04719872159971	K103497	000
04719872159988	K103497	000
04719872159995	K103497	000
04719872160007	K103497	000
04719872160014	K103497	000
04719872160021	K103497	000
04719872160038	K103497	000
04719872160045	K103497	000
04719872160069	K103497	000
04719872160076	K103497	000
04719872174073	K103497	000