FDA 510(k) Application Details - K101472

Device Classification Name	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented   More FDA Info for this Device
510(K) Number	K101472
Device Name	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Applicant	OTIS BIOTECH CO., LTD 514, 2-BA BLOCK JEONGWANG-DONG SIHEUNG-SI, GYOUNGGI-DO 429-450 KR Other 510(k) Applications for this Company
Contact	SRINIVASAREDDY KROTHA Other 510(k) Applications for this Contact
Regulation Number	888.3353   More FDA Info for this Regulation Number
Classification Product Code	LZO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/27/2010
Decision Date	01/05/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review