FDA 510(k) Application Details - K990322

Device Classification Name	Rod, Fixation, Intramedullary And Accessories   More FDA Info for this Device
510(K) Number	K990322
Device Name	Rod, Fixation, Intramedullary And Accessories
Applicant	PIONEER SURGICAL TECHNOLOGY 375 RIVER PARK CIRCLE MARQUETTE, MI 49855-0627 US Other 510(k) Applications for this Company
Contact	BURNS SEVERSON 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	02/02/1999
Decision Date	04/01/1999
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