FDA 510(k) Application Details - K132600

Device Classification Name Plate, Bone

  More FDA Info for this Device
510(K) Number K132600
Device Name Plate, Bone
Applicant BIOMET MICROFIXATION
1520 TRADEPORT DR.
JACKSONVILLE, FL 32218 US
Other 510(k) Applications for this Company
Contact ELIZABETH WHEELER
Other 510(k) Applications for this Contact
Regulation Number 872.4760

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

  More FDA Info for this Product Code
Date Received 08/20/2013
Decision Date 10/02/2013
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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