FDA 510(k) Application Details - K051973

Device Classification Name Appliance, Fixation, Spinal Interlaminal

  More FDA Info for this Device
510(K) Number K051973
Device Name Appliance, Fixation, Spinal Interlaminal
Applicant STRYKER SPINE
2 PEARL COURT
ALLENDALE, NJ 07401 US
Other 510(k) Applications for this Company
Contact SIMONA VOIC
Other 510(k) Applications for this Contact
Regulation Number 888.3050

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

  More FDA Info for this Product Code
Date Received 07/21/2005
Decision Date 08/18/2005
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