FDA 510(k) Application Details - K971135

Device Classification Name	Rod, Fixation, Intramedullary And Accessories   More FDA Info for this Device
510(K) Number	K971135
Device Name	Rod, Fixation, Intramedullary And Accessories
Applicant	WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. ARLINGTON, TN 38002 US Other 510(k) Applications for this Company
Contact	CRISTIE MANUEL Other 510(k) Applications for this Contact
Regulation Number	888.3020   More FDA Info for this Regulation Number
Classification Product Code	HSB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/27/1997
Decision Date	06/05/1997
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