FDA 510(k) Application Details - K043310

Device Classification Name	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment   More FDA Info for this Device
510(K) Number	K043310
Device Name	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
Applicant	SYNTHES (USA) 1690 RUSSELL RD. PAOLI, PA 19301 US Other 510(k) Applications for this Company
Contact	LISA M BOYLE Other 510(k) Applications for this Contact
Regulation Number	878.4820   More FDA Info for this Regulation Number
Classification Product Code	HWE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/01/2004
Decision Date	01/05/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review