FDA 510(k) Application Details - K093442

Device Classification Name	Plate, Bone, Growth Control, Pediatric, Epiphysiodesis   More FDA Info for this Device
510(K) Number	K093442
Device Name	Plate, Bone, Growth Control, Pediatric, Epiphysiodesis
Applicant	ORTHOFIX INC. 1720 BRAY CENTRAL DR. MCKINNEY, TX 75069 US Other 510(k) Applications for this Company
Contact	MARY BIGGERS Other 510(k) Applications for this Contact
Regulation Number	888.3030   More FDA Info for this Regulation Number
Classification Product Code	OBT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/05/2009
Decision Date	06/10/2010
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