FDA 510(k) Application Details - K121541

Device Classification Name	Cerclage, Fixation   More FDA Info for this Device
510(K) Number	K121541
Device Name	Cerclage, Fixation
Applicant	IMPLANET S.A. 1835 MARKET ST. 29TH FLOOR PHILADELPHIA, PA 19103 US Other 510(k) Applications for this Company
Contact	JANICE M HOGAN Other 510(k) Applications for this Contact
Regulation Number	888.3010   More FDA Info for this Regulation Number
Classification Product Code	JDQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/24/2012
Decision Date	09/13/2012
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