FDA 510(k) Application Details - K123393

Device Classification Name Fastener, Fixation, Biodegradable, Soft Tissue

  More FDA Info for this Device
510(K) Number K123393
Device Name Fastener, Fixation, Biodegradable, Soft Tissue
Applicant SMITH & NEPHEW, INC.
150 MINUTEMAN RD.
ANDOVER, MA 01810 US
Other 510(k) Applications for this Company
Contact SUE DAHLQUIST
Other 510(k) Applications for this Contact
Regulation Number 888.3030

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

  More FDA Info for this Product Code
Date Received 11/02/2012
Decision Date 04/11/2013
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