FDA 510(k) Application Details - K051309

Device Classification Name	Screw, Fixation, Bone   More FDA Info for this Device
510(K) Number	K051309
Device Name	Screw, Fixation, Bone
Applicant	REILEY ORTHOPAEDICS, INC. 1001 OAKWOOD BLVD. ROUND ROCK, TX 78681 US Other 510(k) Applications for this Company
Contact	J.D. WEBB 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	05/19/2005
Decision Date	07/11/2005
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