FDA 510(k) Application Details - K043206

Device Classification Name	Spinal Vertebral Body Replacement Device   More FDA Info for this Device
510(K) Number	K043206
Device Name	Spinal Vertebral Body Replacement Device
Applicant	PIONEER SURGICAL TECHNOLOGY 375 RIVER PARK CIRCLE MARQUETTE, MI 49855-0627 US Other 510(k) Applications for this Company
Contact	JONATHAN M GILBERT Other 510(k) Applications for this Contact
Regulation Number	888.3060   More FDA Info for this Regulation Number
Classification Product Code	MQP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/19/2004
Decision Date	01/21/2005
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