FDA 510(k) Application Details - K140625

Device Classification Name

  More FDA Info for this Device
510(K) Number K140625
Device Name ORTHOSORB LS
Applicant BIOMET, INC.
56 EAST BELL DR.
BOX 587
WARSAW, IN 46581-0587 US
Other 510(k) Applications for this Company
Contact VICTORIA SCHEITLIN
Other 510(k) Applications for this Contact
Regulation Number

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

  More FDA Info for this Product Code
Date Received 03/11/2014
Decision Date 04/18/2014
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