FDA 510(k) Application Details - K073151

Device Classification Name Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease

  More FDA Info for this Device
510(K) Number K073151
Device Name Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease
Applicant STRYKER CORP.
2 PEARL COURT
ALLENDALE, NJ 07401 US
Other 510(k) Applications for this Company
Contact CURTIS TRUESDALE
Other 510(k) Applications for this Contact
Regulation Number 888.3070

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

  More FDA Info for this Product Code
Date Received 11/08/2007
Decision Date 12/06/2007
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