FDA 510(k) Application Details - K100414

Device Classification Name Pin, Fixation, Threaded

  More FDA Info for this Device
510(K) Number K100414
Device Name Pin, Fixation, Threaded
Applicant MERETE MEDICAL GMBH
ALT LANKWITZ 102
BERLIN 12247 DE
Other 510(k) Applications for this Company
Contact EMMANUEL ANAPLIOTIS
Other 510(k) Applications for this Contact
Regulation Number 888.3040

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

  More FDA Info for this Product Code
Date Received 02/16/2010
Decision Date 07/02/2010
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