FDA 510(k) Application Details - K112197

Device Classification Name Pin, Fixation, Smooth

  More FDA Info for this Device
510(K) Number K112197
Device Name Pin, Fixation, Smooth
Applicant MEMOMETAL TECHNOLOGIES
CAMPUS DE KER LANN
RUE BLAISE PASCAL
BRUZ F35170 FR
Other 510(k) Applications for this Company
Contact GILLES AUDIC
Other 510(k) Applications for this Contact
Regulation Number 888.3040

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

  More FDA Info for this Product Code
Date Received 08/01/2011
Decision Date 11/17/2011
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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