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FDA 510(k) Application Details - K133557
Device Classification Name
Intervertebral Fusion Device With Bone Graft, Lumbar
More FDA Info for this Device
510(K) Number
K133557
Device Name
Intervertebral Fusion Device With Bone Graft, Lumbar
Applicant
SPINEART
COINTRIN 20 ROUTE DE PRE-BOIS
CP1813
GENEVA 1215 CH
Other 510(k) Applications for this Company
Contact
FRANCK PENNESI
Other 510(k) Applications for this Contact
Regulation Number
888.3080
More FDA Info for this Regulation Number
Classification Product Code
MAX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/19/2013
Decision Date
02/03/2014
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
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