FDA 510(k) Application Details - K053115

Device Classification Name	Orthosis, Spinal Pedicle Fixation   More FDA Info for this Device
510(K) Number	K053115
Device Name	Orthosis, Spinal Pedicle Fixation
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	888.3070   More FDA Info for this Regulation Number
Classification Product Code	MNI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/07/2005
Decision Date	12/06/2005
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