FDA 510(k) Application Details - K003788

Device Classification Name Plate, Fixation, Bone

  More FDA Info for this Device
510(K) Number K003788
Device Name Plate, Fixation, Bone
Applicant SYNTHES (USA)
P.O. BOX 1766
1690 RUSSELL ROAD
PAOLI, PA 19301-1222 US
Other 510(k) Applications for this Company
Contact THOMAS M MAGUIRE
Other 510(k) Applications for this Contact
Regulation Number 888.3030

  More FDA Info for this Regulation Number
Classification Product Code HRS
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 12/08/2000
Decision Date 05/30/2001
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



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact