FDA 510(k) Application Details - K151762

Device Classification Name Staple, Fixation, Bone

  More FDA Info for this Device
510(K) Number K151762
Device Name Staple, Fixation, Bone
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 888.3030

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

  More FDA Info for this Product Code
Date Received 06/29/2015
Decision Date 12/28/2015
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