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FDA 510(k) Application Details - K100820
Device Classification Name
Intervertebral Fusion Device With Bone Graft, Lumbar
More FDA Info for this Device
510(K) Number
K100820
Device Name
Intervertebral Fusion Device With Bone Graft, Lumbar
Applicant
WENZEL SPINE
2720 BEE CAVE ROAD
AUSTIN, TX 78746 US
Other 510(k) Applications for this Company
Contact
SOURABH MISHRA
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
03/23/2010
Decision Date
08/05/2010
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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