FDA 510(k) Application Details - K980484

Device Classification Name	Orthosis, Spinal Pedicle Fixation   More FDA Info for this Device
510(K) Number	K980484
Device Name	Orthosis, Spinal Pedicle Fixation
Applicant	AESCULAP, INC. 1000 GATEWAY BLVD. SOUTH SAN FRANCISCO, CA 94080 US Other 510(k) Applications for this Company
Contact	LIA SPASARO 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	02/09/1998
Decision Date	10/02/1998
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