FDA 510(k) Application Details - K101356

Device Classification Name	Prosthesis, Hip, Hemi-, Femoral, Metal   More FDA Info for this Device
510(K) Number	K101356
Device Name	Prosthesis, Hip, Hemi-, Femoral, Metal
Applicant	TECRES SPA 7 Trail House Court Rockville, MD 20850 US Other 510(k) Applications for this Company
Contact	CHRISTINE BRAUER Other 510(k) Applications for this Contact
Regulation Number	888.3360   More FDA Info for this Regulation Number
Classification Product Code	KWL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/14/2010
Decision Date	09/20/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review