FDA 510(k) Application Details - K142587

Device Classification Name Prosthesis, Rib Replacement

  More FDA Info for this Device
510(K) Number K142587
Device Name Prosthesis, Rib Replacement
Applicant Depuy Synthes Spine, Inc.
325 Paramount Drive
Raynham, MA 02767 US
Other 510(k) Applications for this Company
Contact Catherine Kilshaw
Other 510(k) Applications for this Contact
Regulation Number 000.0000

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

  More FDA Info for this Product Code
Date Received 09/15/2014
Decision Date 11/18/2014
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