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FDA 510(k) Application Details - K132732
Device Classification Name
Intervertebral Fusion Device With Bone Graft, Cervical
More FDA Info for this Device
510(K) Number
K132732
Device Name
Intervertebral Fusion Device With Bone Graft, Cervical
Applicant
MEDYSSEY USA, INC.
1550 E. HIGGINS ROAD, STE 123
ELK GROVE VILLAGE, IL 60007 US
Other 510(k) Applications for this Company
Contact
JOHN KUCZYNSKI
Other 510(k) Applications for this Contact
Regulation Number
888.3080
More FDA Info for this Regulation Number
Classification Product Code
ODP
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/03/2013
Decision Date
07/18/2014
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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