FDA 510(k) Application Details - K030178

Device Classification Name Filler, Bone Void, Calcium Compound

  More FDA Info for this Device
510(K) Number K030178
Device Name Filler, Bone Void, Calcium Compound
Applicant BIOMET, INC.
56 EAST BELL DR.
WARSAW, IN 46581-0587 US
Other 510(k) Applications for this Company
Contact MARY VERSTYNEN
Other 510(k) Applications for this Contact
Regulation Number 888.3045

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

  More FDA Info for this Product Code
Date Received 01/17/2003
Decision Date 02/26/2003
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