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FDA 510(k) Application Details - K103743
Device Classification Name
Intervertebral Fusion Device With Bone Graft, Lumbar
More FDA Info for this Device
510(K) Number
K103743
Device Name
Intervertebral Fusion Device With Bone Graft, Lumbar
Applicant
JOHNSON & JOHNSON
325 PARAMOUNT DR.
RAYNHAM, MA 02767-0151 US
Other 510(k) Applications for this Company
Contact
EUGENE BANG
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
12/23/2010
Decision Date
03/17/2011
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
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