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FDA 510(k) Application Details - K071633
Device Classification Name
Appliance, Fixation, Spinal Interlaminal
More FDA Info for this Device
510(K) Number
K071633
Device Name
Appliance, Fixation, Spinal Interlaminal
Applicant
LANX, LLC
1835 MARKET STREET, 28TH FLOOR
PHILADELPHIA, PA 19102 US
Other 510(k) Applications for this Company
Contact
JANICE HOGAN
Other 510(k) Applications for this Contact
Regulation Number
888.3050
More FDA Info for this Regulation Number
Classification Product Code
KWP
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/14/2007
Decision Date
08/15/2007
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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