FDA 510(k) Application Details - K103284

Device Classification Name	Orthosis, Spine, Plate, Laminoplasty, Metal   More FDA Info for this Device
510(K) Number	K103284
Device Name	Orthosis, Spine, Plate, Laminoplasty, Metal
Applicant	AESCULAP IMPLANT SYSTEMS, INC. 3773 CORPORATE PWKY. CENTER VALLEY, PA 18034 US Other 510(k) Applications for this Company
Contact	LISA M BOYLE Other 510(k) Applications for this Contact
Regulation Number	888.3050   More FDA Info for this Regulation Number
Classification Product Code	NQW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/05/2010
Decision Date	12/02/2010
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