FDA 510(k) Application Details - K955780

Device Classification Name Pin, Fixation, Threaded

  More FDA Info for this Device
510(K) Number K955780
Device Name Pin, Fixation, Threaded
Applicant ZIMMER, INC.
P.O. BOX 708
WARSAW, IN 46581-0708 US
Other 510(k) Applications for this Company
Contact LYNNETTE WHITAKER
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 12/21/1995
Decision Date 02/09/1996
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