FDA 510(k) Application Details - K082574

Device Classification Name	Screw, Fixation, Bone   More FDA Info for this Device
510(K) Number	K082574
Device Name	Screw, Fixation, Bone
Applicant	ORTHOHELIX SURGICAL DESIGNS, INC. 1815 W. MARKET ST. SUITE 205 AKRON, OH 44313 US Other 510(k) Applications for this Company
Contact	DEREK LEWIS Other 510(k) Applications for this Contact
Regulation Number	888.3040   More FDA Info for this Regulation Number
Classification Product Code	HWC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/05/2008
Decision Date	12/08/2008
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